Library / Laws / 113th / s / S. 696 / Introduced in Senate
II
113th CONGRESS
1st Session
S. 696
IN THE SENATE OF THE UNITED STATES
April 10, 2013
Mr. Reid (for
Mr. Lautenberg (for himself,
Mrs. Gillibrand,
Mr. Schumer, Mr. Durbin, Mrs.
Murray, Mrs. Boxer,
Mr. Udall of New Mexico,
Mr. Baucus, Ms.
Mikulski, Mr. Bennet,
Ms. Klobuchar, Mr. Franken, Mr.
Tester, Mr. Whitehouse,
Mrs. Feinstein, Mr. Blumenthal, Mr.
Cowan, Mr. Sanders,
Ms. Warren, Mr.
Harkin, Mr. Merkley,
Mr. Wyden, Mr.
Cardin, Mr. Leahy,
Mr. Menendez, Mr. Schatz, Mr.
Nelson, Ms. Cantwell, and
Mr. King)) introduced the following bill;
which was read twice and referred to the Committee on Environment and Public
Works
A BILL
To amend the Toxic Substances Control Act to ensure that
risks from chemicals are adequately understood and managed, and for other
purposes.
1.
Short
title
This Act may be cited as
the Safe Chemicals Act of
2013.
2.
Purposes
The purpose of this Act is to ensure that
risks from chemicals are adequately understood and managed.
3.
Findings,
policy, and goal
Section 2 of
the Toxic Substances Control Act (15 U.S.C. 2601) is amended—
(1) in the heading,
by striking Intent and inserting
Goal; and
(2) by striking
subsections (a) through (c) and inserting the following:
(a)
Findings
Congress
finds that—
(1) each year human
beings and the environment are exposed to a large number of chemical
substances;
(2) the chemical
industry, an important part of the United States economy, provides valuable
products that are used in diverse manufacturing industries and other
commercial, institutional, and consumer applications;
(3) more than 3
decades after the enactment of this Act, people and the environment in the
United States are still exposed to thousands of chemicals whose safety has not
been adequately reviewed and may harm health and the environment;
(4) the incidence of
some diseases and disorders linked to chemical substance exposures is on the
rise;
(5) biomonitoring of
chemical substances in humans reveals that people in the United States carry
hundreds of hazardous chemicals in their bodies;
(6) the
concentrations of certain chemical substances that persist and accumulate are
increasing in the environment and in human bodies and are found across the
world, including in the remote Arctic in which Native Americans face increasing
contamination of traditional foods;
(7) differences in
metabolism and physiology at certain stages of development can make infants and
children more vulnerable than adults to the effects of chemical exposure,
especially exposure that occurs in utero, during infancy, and during other
critical periods of development;
(8) manufacturers and
processors of chemicals should supply sufficient health and environmental
information before distributing products in commerce;
(9) the Administrator
must have and exercise the authority to develop sufficient information to
assess chemical safety, and to act effectively when the Administrator obtains
information that indicates there are risks of harmful exposure to chemical
substances;
(10) there is
significant global trade in the chemical sector and many of the companies that
conduct business in the United States must also comply with chemical safety
regulatory programs in other countries, and the data that is generated to
comply with those other regulatory programs may be useful in understanding
hazards and exposures of chemical substances presented in the United States;
and
(11) a revised policy
on the safety of chemical substances will assist in renewing the manufacturing
sector of the United States, create new and safer jobs, spur innovations in
green chemistry, restore confidence domestically and internationally in the
safety of products of the United States, and ensure that products of the United
States remain competitive in the global market.
(b)
Policy
It
is the policy of the United States—
(1) to protect the
health of children, workers, consumers, and the public, and to protect the
environment from harmful exposures to chemical substances;
(2) to promote the
use of safer alternatives and other actions that reduce the use of and exposure
to hazardous chemical substances and reward innovation toward safer chemicals,
processes, and products;
(3) to require that
chemicals in commerce meet a risk-based safety standard that protects
vulnerable and affected populations and the environment;
(4) to require
companies to provide sufficient health and environmental information for the
chemical substances that the companies manufacture, process, or import as a
condition of allowing those companies to distribute chemical substances in
commerce;
(5) to improve the
quality of information on chemical safety and use;
(6) to guarantee the
right of the public and workers to know about the hazards and uses of chemical
substances that the public and workers may be exposed to by maximizing public
access to information on chemical safety and use; and
(7) to strengthen
cooperation between and among the Federal Government and State, municipal,
tribal, and foreign governments.
(c)
Goal
It
is the goal of the United States to address the harmful exposure of vulnerable
or affected populations to chemical substances caused by the distribution of
chemical substances in commerce by—
(1) reviewing all
chemical substances for safety and identifying the highest priority chemical
substances for expedited review;
(2) determining
whether chemical substances in commerce meet the safety standard under this
title;
(3) applying
appropriate restrictions to the use of a chemical substance, where warranted;
and
(4) encouraging the
replacement of harmful chemicals and processes with safer
alternatives.
.
4.
Definitions
Section 3 of the Toxic Substances Control
Act (15 U.S.C. 2602) is amended—
(1) by striking
paragraph (12);
(2) by redesignating
paragraphs (2), (3), (4), (5), (6), (7), (8), (9), (10), (11), (13), and (14),
as paragraphs (5), (6), (8), (10), (12), (13), (14), (15), (18), (19), (21),
and (24), respectively;
(3) by inserting
after paragraph (1) the following:
(2)
Aggregate
exposure
(A)
In
general
Subject to subparagraph (B), the term aggregate
exposure means exposure from all sources of a chemical substance,
including exposure from—
(i) the manufacture,
processing, distribution, use, and disposal of that chemical substance;
and
(ii) all other
sources of that chemical substance, including—
(I) contamination of
food, air, water, soil, and house dust from current or prior uses or
activity;
(II) accidental
releases;
(III) permitted
sources of pollution;
(IV) nonpoint sources
of pollution;
(V) documented
background levels from natural and anthropogenic sources; and
(VI) a mixture or
article containing that chemical substance.
(B)
Inclusions
The
term aggregate exposure includes exposure from a chemical
substance that is not considered to be a chemical substance under this Act
solely because of the use of that substance as, or in, a food, food additive,
cosmetic, or device (as those terms are defined in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321)).
(3)
Bioaccumulative
(A)
In
general
The term bioaccumulative means, with respect
to a chemical substance or mixture, that the chemical substance or mixture, as
determined by the Administrator, can significantly accumulate in biota, as
indicated through monitoring data, or is highly likely to accumulate in biota,
as indicated by other evidence.
(B)
Update
To
reflect the best available science, the Administrator may, by rule, revise the
definition of the term bioaccumulative in such a way that reflects
the state of the science and provides for equal or greater protection of human
health and the environment.
(4)
Chemical
identity
The term chemical identity includes—
(A) each common and
trade name of a chemical substance;
(B) the name of a
chemical substance appearing in International Union of Pure and Applied
Chemistry nomenclature and the most current Collective Index format;
(C) each Chemical
Abstracts Service registration number of a chemical substance; and
(D) the molecular
structure of a chemical
substance.
;
(4) in paragraph (5)
(as redesignated by paragraph (2))—
(A) by striking
(2)(A) Except as provided in subparagraph (B) and inserting the
following:
(5)
Chemical
substance
(A)
In
general
Except as provided in subparagraphs (B) and
(C)
;
(B) in subparagraph
(B), by striking (B) Such term and inserting the
following:
(B)
Exclusions
The
term chemical substance
;
and
(C) by adding at the
end the following:
(C)
Inclusions
Notwithstanding
molecular identity, the Administrator may determine that a variant of a
chemical substance is a new chemical substance under section
5(a)(6).
;
(5) by inserting
after paragraph (6) (as redesignated by paragraph (2)) the following:
(7)
Cumulative
exposure
The term cumulative exposure means the sum
of aggregate exposure to each of the chemical substances that are known or
suspected to contribute appreciably to the risk of the same or a similar
adverse
effect.
;
(6) by striking
paragraph (8) (as redesignated by paragraph (2)) and inserting the
following:
(8)
Distribute in
commerce
The terms distribute in commerce and
distribution in commerce, when used to describe an action taken
with respect to a chemical substance (or mixture or article containing that
chemical substance), mean—
(A) to sell, or the
sale of, the substance, mixture, or article in commerce;
(B) to introduce or
deliver for introduction into commerce, or the introduction or delivery for
introduction into commerce of, the substance, mixture, or article;
(C) to hold, or the
holding of, the substance, mixture, or article after its introduction into
commerce; or
(D) to export or
offer for export the substance, mixture, or
article.
;
(7) by inserting
after paragraph (8) (as redesignated by paragraph (2)) the following:
(9)
End
consumer
The term end consumer means an individual
or other entity that purchases and uses or consumes a chemical substance (or
mixture or article containing that chemical
substance).
;
(8) in paragraph (10)
(as redesignated by paragraph (2)), by inserting ambient and
indoor after includes water,;
(9) by inserting
after paragraph (10) (as redesignated by paragraph (2)) the following:
(11)
Federal
agency
The term Federal agency means any department,
agency, or other instrumentality of the Federal Government, any independent
agency or establishment of the Federal Government including any Government
corporation, and the Government Printing
Office.
;
(10) in paragraph
(15) (as redesignated by paragraph (2)), by striking which is not
included in the chemical substance list compiled and published under section
8(b) and inserting for which the manufacturer or processor of
the chemical substance has not submitted a declaration under section
8(a);
(11) by inserting
after paragraph (15) (as redesignated by paragraph (2)) the following:
(16)
Persistent
(A)
In
general
The term persistent means, with respect to a
chemical substance or mixture, that the chemical substance or mixture, as
determined by the Administrator, significantly persists in 1 or more
environmental media, as indicated by monitoring data or other evidence.
(B)
Update
To
reflect the best available science, the Administrator may, by rule, revise the
definition of the term persistent in such a way that reflects the
state of the science and provides for equal or greater protection of human
health and the environment.
(17)
Person
(A)
In
general
The term person means an individual, trust,
firm, joint stock company, corporation (including a Government corporation),
partnership, association, State, municipality, commission, political
subdivision of a State, or any interstate body.
(B)
Inclusions
The
term person includes each Federal agency and any officer, agent,
or employee of a Federal
agency.
;
(12) by inserting
after paragraph (19) (as redesignated by paragraph (2)) the following:
(20)
Special
substance characteristic
(A)
In
general
The term special substance characteristic
means a physical, chemical, or biological characteristic, other than molecular
identity, that the Administrator determines, by order or rule, may
significantly affect the risks posed by substances exhibiting that
characteristic.
(B)
Considerations
In
determining the existence of special substance characteristics, the
Administrator may consider—
(i) size or size
distribution;
(ii) shape and
surface structure;
(iii) reactivity;
and
(iv) any other
properties that may significantly affect the risks
posed.
;
(13) by inserting
after paragraph (21) (as redesignated by paragraph (2)) the following:
(22)
Toxic
The
term toxic, with respect to a chemical substance or mixture, means
that the chemical substance or mixture has a toxicological property—
(A) meeting the
criteria for Category 1 or Category 2 for any of the toxicity endpoints
established by the Globally Harmonized System for the Classification and
Labeling of Hazardous Substances;
(B) that causes an
adverse effect that has been demonstrated in humans or other exposed organisms;
or
(C) for which the
weight of evidence (such as demonstration of an adverse effect described in
subparagraph (B), laboratory studies, or data for a chemical from the same
chemical class that exhibits that adverse effect) demonstrates the potential
for an adverse effect in humans or other exposed organisms.
(23)
Toxicological
property
The term toxicological property means
actual or potential toxicity or other adverse effects of a chemical substance
or mixture, including actual or potential effects of exposure to a chemical
substance or mixture on—
(A) mortality;
(B) morbidity,
including carcinogenesis;
(C) reproduction;
(D) growth and
development;
(E) the immune
system;
(F) the endocrine
system;
(G) the brain or
nervous system;
(H) other organ
systems; or
(I) any other
biological functions in humans or nonhuman organisms.
;
and
(14) by adding at the
end the following:
(25)
Vulnerable
human population
The term vulnerable human
population means a human population that is subject to disproportionate
exposure to, or the potential for disproportionate adverse effect from exposure
to, a chemical substance or mixture, including—
(A) infants,
children, and adolescents;
(B) pregnant
women;
(C) elderly;
(D) individuals with
preexisting medical conditions;
(E) workers that work
with chemical substances and mixtures; and
(F) members of any
other appropriate population identified by the
Administrator.
.
5.
Minimum
information sets and testing of chemical substances
Section 4 of the Toxic Substances Control
Act (15 U.S.C. 2603) is amended to read as follows:
4.
Minimum
information sets and testing of chemical substances
(a)
Minimum
information sets
(1)
Rule
(A)
In
general
Subject to subparagraphs (B) and (C), and not later than
1 year after the date of enactment of the Safe Chemicals Act of 2013, the
Administrator shall establish, by rule, such minimum information sets as the
Administrator determines to be appropriate to evaluate chemical substances
under sections 5 and 6.
(B)
General
requirements
The rule promulgated pursuant to subparagraph (A)
shall—
(i) provide for
varied or tiered information to be provided for different chemical
substances;
(ii) identify the
particular minimum information set that applies to a chemical substance;
(iii) require each
minimum information set to include sufficient information for the Administrator
to conduct a screening-level risk assessment of the chemical substance,
including information on the characteristics, toxicological properties,
environmental and biological fate and behavior, exposure, and use of a chemical
substance;
(iv) specify
information quality and reliability requirements applicable to the information
submitted in the minimum information sets; and
(v) accommodate the
use of alternative testing methods and testing strategies to generate
information quickly, at low cost, and with reduced use of animal-based testing,
including toxicity pathway-based risk assessment, in vitro studies, systems
biology, computational toxicology, bioinformatics, and high-throughput
screening, to the extent such methods and strategies would yield information of
equivalent quality and reliability.
(C)
Specific
requirements
The rule promulgated pursuant to subparagraph (A)
shall establish minimum information sets sufficient for the Administrator to
administer this Act, including to carry out—
(i) categorization of
new chemical substances under section 5(b)(2), including the identification of
information—
(I) sufficiently
robust to generally support the categorization of a new chemical substance as a
substance of very low concern under section 5(b)(2)(D)(iii)(II); and
(II) in the absence
of which the Administrator shall designate a new chemical substance to be a
substance with insufficient information under section 5(b)(2)(D)(iv);
(ii) categorization
of existing chemical substances under section 6(b)(3), including the
identification of information—
(I) sufficiently
robust to generally support the categorization of an existing chemical
substance as a substance of very low concern under section 6(b)(3)(B)(ii);
and
(II) in the absence
of which the Administrator shall designate an existing chemical substance to be
a substance with insufficient information under section 6(b)(3)(B)(iv);
(iii) assignment of
chemical substances to priority classes under section 6(b)(4);
(iv) safety standard
determinations—
(I) for new uses of
existing chemical substances under section 5(b)(2); and
(II) for chemical
substances under section 6(d); and
(v) safety standard
redeterminations under section 6(d)(5)(E).
(2)
Submission of
minimum information set
Each manufacturer and processor of a
chemical substance shall submit the minimum information set for the chemical
substance to the Administrator—
(A) for new chemical
substances, concurrent with the notice required under section (5)(b)(1)(A);
and
(B) for existing
chemical substances, as specified in section 6 or otherwise specified by the
Administrator in the rule promulgated pursuant to paragraph (1)(A).
(3)
Prohibition
In
addition to any other authorities available under this Act, the Administrator
may, by order, take any action authorized under section 6(f) if a manufacturer
or processor is in violation of paragraph (2).
(b)
Testing
(1)
General
submissions
(A)
In
general
The Administrator may, by rule or order, require testing
with respect to any chemical substance, and the submission of test results by a
specified date, as appropriate for making any determination or carrying out any
provision of this Act. Such testing may be required—
(i) to provide
information in addition to the information specified in any applicable minimum
information set under subsection (a); and
(ii) of persons to
whom the Administrator decides not to apply a requirement to submit a minimum
information set under subsection (a).
(B)
Effect on other
authority
Nothing in this paragraph limits the authority of the
Administrator under paragraph (2).
(2)
Sample
submissions
(A)
In
general
The Administrator may, by rule or order, require the
submission of a sample of any chemical substance in such manner as the
Administrator determines enables the Administrator to conduct any tests
necessary for making any determination or carrying out any provision of this
Act.
(B)
Effect on other
authority
Nothing in this paragraph limits the authority of the
Administrator under paragraph (1).
(3)
Prohibition
In
addition to any other authorities available under this Act, the Administrator
may, by order, take any action authorized under section 6(f) if a manufacturer
or processor is in violation of a rule or order under paragraph (1).
(4)
Exemption
If
a manufacturer or processor ceases all manufacture or processing of a chemical
substance pursuant to its submission of a declaration of cessation of
manufacture or processing under section 8(b)(4) for the chemical substance, the
manufacturer or processor shall be exempted from the requirements of this
subsection.
(c)
Test rules or
orders
(1)
In
general
A rule or order issued under subsection (b) shall
include—
(A) identification of
the chemical substance for which testing is required under the rule or
order;
(B) standards for the
development of test information for that substance; and
(C) a specification
of the period (which may not be of unreasonable duration) within which the
persons required to conduct the testing shall submit to the Administrator
information developed in accordance with the standards referred to in
subparagraph (B).
(2)
Considerations
(A)
In
general
In determining the standards and period to be required
under subparagraphs (B) and (C) of paragraph (1), the Administrator shall
consider—
(i) the relative
costs of the various test protocols and methodologies that may be required
under the rule or order; and
(ii) the reasonably
foreseeable availability of the facilities and personnel needed to perform the
testing required under the rule.
(B)
Preliminary
information
Any rule or order issued by the Administrator under
this subsection may require a manufacturer or processor to submit preliminary
information during the period described in paragraph (1)(C).
(3)
Types of health
and environmental information
(A)
In
general
The Administrator may prescribe standards for the
development of test information under this subsection for health and
environmental information, including—
(i) information
pertaining to carcinogenesis, mutagenesis, teratogenesis, behavioral disorders,
or cumulative, synergistic, or any other effect that may be considered in a
safety standard determination;
(ii) information
pertaining to exposure to the chemical substance, including information
regarding the presence of the chemical substance in human blood, fluids, or
tissue; and
(iii) information
pertaining to—
(I) bioaccumulation;
(II) persistence;
(III) acute
toxicity;
(IV) subacute
toxicity;
(V) chronic toxicity;
and
(VI) any other
characteristic that may present an adverse effect.
(B)
Methodologies
(i)
In
general
The Administrator may prescribe methodologies in
standards for the development of test information, including—
(I) epidemiologic
studies;
(II) biomonitoring or
environmental monitoring studies;
(III) serial or
hierarchical tests;
(IV) in vitro
tests;
(V) whole animal
tests, consistent with section 30; and
(VI) any other
methodology deemed appropriate by the Administrator.
(ii)
Requirement
Prior
to prescribing epidemiologic studies of employees, the Administrator shall
consult with the Director of the National Institute for Occupational Safety and
Health.
(C)
Review
Periodically,
but not less frequently than once every 3 years, the Administrator
shall—
(i) review the
adequacy of the standards for development of information prescribed under
subparagraph (A); and
(ii) if necessary,
institute proceedings to make appropriate revisions of those standards.
(4)
Persons
required to conduct tests and submit information
(A)
In
general
Except as provided in subparagraph (B), a rule or order
under subsection (b) respecting a chemical substance shall specify the persons
required to conduct tests and submit information to the Administrator on the
substance.
(B)
Exception
The
Administrator may permit 2 or more of the persons described in subparagraph (A)
to designate 1 of the persons or a qualified third party to conduct the tests
and submit the information on behalf of the persons making the
designation.
(C)
Liability
All
persons described in subparagraphs (A) and (B) shall remain liable for
compliance with any requirements subject to the designation.
(5)
Expiration of
rules and orders
(A)
In
general
Any rule or order under subsection (b) that requires the
testing and submission of information for a particular chemical substance shall
expire at the end of the applicable reimbursement period (as defined in
subsection (d)(3)) unless, prior to that date, the Administrator withdraws the
rule or order.
(B)
Category of
chemical substances
A rule or order under subsection (b) that
requires the testing and submission of information for a category of chemical
substances shall expire with respect to a chemical substance included in the
category at the end of the applicable reimbursement period (as defined in
subsection (d)(3)) unless, prior to that date, the Administrator withdraws the
rule or order with respect to the substance entirely.
(d)
Exemptions
(1)
In
general
Any person required by a rule or order under subsections
(a) or (b) to conduct tests and submit information for a chemical substance may
apply to the Administrator (in such form and manner as the Administrator
determines necessary) for an exemption from the requirement.
(2)
Action by
Administrator
In accordance with paragraph (3) or (4), the
Administrator shall exempt an applicant under paragraph (1), if, on receipt of
the application, the Administrator determines that—
(A) the chemical
substance for which the application was submitted is equivalent to a chemical
substance for which—
(i) information has
been submitted to the Administrator in accordance with a rule or order under
subsection (a) or (b); or
(ii) information is
being developed in accordance with the rule or order; and
(B) submission of
information by the applicant for the substance would be duplicative of
information that—
(i) has been
submitted to the Administrator in accordance with the rule or order under
subsection (a) or (b); or
(ii) is being
developed in accordance with the rule or order.
(3)
Reimbursement
due to exemption
(A)
Definition of
reimbursement period
In this paragraph, the term
reimbursement period, with respect to any test information for a
chemical substance, means a period that—
(i) begins on the
date on which the test information is submitted in accordance with a rule or
order issued under subsection (a) or (b); and
(ii) ends on the
later of—
(I) 5 years after the
date referred to in clause (i); and
(II) the date which,
as determined by the Administrator, provides the applicant with a time period
which is sufficient to develop the test information.
(B)
Reimbursement
for previously submitted test information
(i)
In
general
Except as provided in clause (ii), for an exemption under
paragraph (2)(B)(i), if the exemption is granted during the reimbursement
period for the test information, the Administrator shall order the person
granted the exemption to provide fair and equitable reimbursement (in an amount
determined by the Administrator) to—
(I) the person who
previously submitted the test information, for a portion of the costs incurred
by the person in complying with the information submission requirement;
and
(II) any other person
who has been required under this subsection to contribute with respect to the
costs, for a portion of the amount the person was required to
contribute.
(ii)
Exception
Clause
(i) shall not apply if there is agreement on the amount and method of
reimbursement between an exempted person described in clause (i) and the
persons described in subclauses (I) and (II) of that clause.
(iii)
Considerations
In
promulgating rules for the determination of fair and equitable reimbursement to
the persons described in subclauses (I) and (II) of clause (i) for costs
incurred with respect to a chemical substance, the Administrator shall, after
consultation with the Attorney General and the Federal Trade Commission,
consider all relevant factors, including—
(I) the effect on the
competitive position of the person required to provide reimbursement in
relation to the person to be reimbursed; and
(II) the share of the
market for the substance of the person required to provide reimbursement in
relation to the share of the market of the persons to be reimbursed.
(C)
Reimbursement
due to exemption for test information being developed in accordance with rule
or order
(i)
In
general
Except as provided in clause (ii), for an exemption under
paragraph (2)(B)(ii), the Administrator shall order the person granted the
exemption to provide fair and equitable reimbursement (in an amount determined
by the Administrator) to—
(I) each person who
is developing the test information, for the portion of the costs incurred by
each person in complying with the rule or order; and
(II) any other person
who has been required under this subsection to contribute with respect to the
costs of complying with the rule or order, for a portion of the amount the
person was required to contribute.
(ii)
Exception
Clause
(i) shall not apply if there is agreement on the amount and method of
reimbursement between an exempted person described in clause (i) and the
persons described in subclauses (I) and (II) of that clause.
(iii)
Considerations
In
promulgating rules for the determination of fair and equitable reimbursement to
the persons described in subclauses (I) and (II) of clause (i) for costs
incurred with respect to a chemical substance, the Administrator shall, after
consultation with the Attorney General and the Federal Trade Commission,
consider the factors described in subparagraph (B)(iii).
(iv)
Lack of
compliance
If any exemption is granted under paragraph (2) on the
basis that 1 or more persons are developing test information pursuant to a rule
or order promulgated or issued under subsection (a) or (b), and after the
exemption is granted, the Administrator determines that no person has complied
with the rule or order, the Administrator shall—
(I) after providing
written notice and an opportunity for a hearing to the person who holds the
exemption, by order, terminate the exemption; and
(II) notify in
writing the person of the requirements of the rule or order with respect to
which the exemption was granted.
(e)
Notice
(1)
In
general
Not later than 15 days after the date of receipt of any
test information pursuant to a rule or order under subsection (a) or (b), the
Administrator shall publish in the Federal Register a notice of the receipt of
the test information.
(2)
Requirements
Subject
to section 14, each notice shall—
(A) identify the
chemical substance for which information has been received;
(B) list—
(i) the commercial
and consumer uses or intended commercial and consumer uses of the substance
known to the Administrator; and
(ii) the information
required by the applicable standards for the development of test information;
and
(C) describe the
nature of the test information developed.
(3)
Availability
Subject
to section 14, the Administrator shall make the test information described in
this subsection available on a publicly accessible Internet site.
(f)
Requests from
other agencies for additional information or testing
(1)
In
general
The head of a Federal agency may request the
Administrator to seek the information on behalf of that agency if the head of
that Federal agency determines that—
(A) information
relating to a chemical substance, including information derived from new
testing or monitoring, would assist that Federal agency in carrying out the
duties or exercising the authority of that agency; but
(B) the requested
information is not available to that agency.
(2)
Duty of
Administrator
Not later than 60 days after the date of receipt of
a request under paragraph (1), the Administrator shall—
(A) subject to
section 14, make the information available to the requesting agency or
institution;
(B) issue a request
under section 8(k) to require—
(i) the submission of
existing pertinent information to the Administrator; and
(ii) a copy of any
such submission to be furnished to the requesting agency or institution;
(C) issue a rule or
order under subsection (b)—
(i) to develop the
information; and
(ii) to require the
developed information to be furnished to the requesting agency or institution;
or
(D) publish in the
Federal Register the reason for which none of the actions described in this
paragraph were taken.
(g)
Certification
Each
person who submits information under this section or under a rule or an order
promulgated or issued by the Administrator under this section shall accompany
the information with a certification signed by a responsible official that each
statement contained in the submission—
(1) is accurate and
reliable; and
(2) includes all
material facts known to, in the possession or control of, or reasonably
ascertainable by, the
person.
.
6.
New chemical
substances and new uses of chemical substances
Section 5 of the Toxic Substances Control
Act (15 U.S.C. 2604) is amended to read as follows:
5.
New chemical
substances and new uses of chemical substances
(a)
Definitions
In
this section:
(1)
Manufacture and
process
The terms manufacture and
process mean manufacture or process, respectively, for commercial
purposes.
(2)
Test
marketing
The term test marketing does not include
any provision of a chemical substance or mixture, or an article containing a
chemical substance or mixture, to an end consumer of the chemical substance,
mixture, or article.
(b)
New chemical
substances
(1)
Notices
Except
as provided in subsection (h), no person may manufacture a new chemical
substance, or process the chemical substance for a use that is proposed to meet
the criteria described in section 6(h)(2)(B), unless—
(A) the person
submits to the Administrator a notice, in accordance with subsection (g)(1)(A),
of the intention of the person to manufacture or process the substance;
(B) the person
complies with subsection (f); and
(C) the Administrator
finds that—
(i) the new chemical
substance is likely to meet the safety standard under section 6(d), which shall
be limited to substances assigned by the Administrator to 1 of the categories
described in paragraph (2)(D)(iii); or
(ii) the person has
established by clear and convincing evidence that 1 or more uses of the new
chemical substance meet the criteria described in section 6(h)(2)(B), in which
case—
(I) the Administrator
may by order allow the person to manufacture or process the substance only for
such use or uses in accordance with subparagraph (A) of section 6(h)(2);
(II) the procedures
and requirements specified in subparagraphs (A), (C), (D), and (E) of section
6(h)(2) shall apply; and
(III) the
Administrator shall not, upon receipt of a notice of commencement for the
chemical substance under subsection (d), add the chemical substance to the
active inventory established under section 8(h)(1).
(2)
Categorization
of new chemical substances
(A)
Rule
Not
later than 1 year after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall promulgate a rule that—
(i) designates the
categories in accordance with subparagraph (D) and specifies the process and
criteria the Administrator will use to categorize new chemical substances;
and
(ii) describes
criteria and factors the Administrator will use to assess weight of evidence
and the quality and reliability of information used to inform categorization
decisions.
(B)
Information
sources
In categorizing a new chemical substance, the
Administrator shall consider information on the substance available to the
Administrator at the time the categorization decision is to be made, including
information—
(i) received by the
Administrator from the manufacturer or processor of the substance in accordance
with subsection (f);
(ii) submitted to a
governmental body in another jurisdiction, to the extent that the information
is accessible to the Administrator;
(iii) derived through
application of validated structure-activity relationship or other models
developed by the Administrator to estimate the environmental and human health
effects, environmental and biological fate and behavior, and exposure potential
of chemical substances;
(iv) inferred based
on the degree of similarity of the structure or properties of the new chemical
substance to those of 1 or more other chemical substances for which reliable
information exists that is relevant to predicting the potential environmental
or human health effects, environmental or biological fate and behavior, or
exposure potential of the new chemical substance; and
(v) any additional
information the Administrator determines is needed to categorize the substance,
including information identified as needed based on the analysis by the
Administrator of estimated or inferred information described in clauses (iii)
and (iv).
(C)
Timing
Not
later than 90 days after the date of receipt of a notice under paragraph
(1)(A), the Administrator shall assign the new chemical substance for which the
notice was submitted to 1 of the categories described in subparagraph
(D).
(D)
Categories
(i)
In
general
The rule promulgated pursuant to subparagraph (A) shall
incorporate, establish criteria for, and further specify as needed, the
categories described in this subparagraph, to 1 of which each new chemical
substance for which a notice is submitted pursuant to paragraph (1) shall be
assigned.
(ii)
Substances of
very high concern
(I)
In
general
The Administrator shall designate as a substance of very
high concern any new chemical substance that—
(aa) is
toxic, persists in the environment, and is bioaccumulative; or
(bb) is
highly hazardous.
(II)
Requirements
(aa)
In
general
The Administrator shall allow the submitter of a notice
under paragraph (1)(A) for a new chemical substance assigned to the category
described in this clause to manufacture or process the new chemical substance
only in accordance with paragraph (1)(C)(ii).
(bb)
Prohibition
No
other person may manufacture or process the chemical substance unless the
person has submitted a notice pursuant to paragraph (1) and the requirements of
paragraph (1)(C)(ii) have been met with respect to that notice.
(iii)
Substances
likely to meet the safety standard
(I)
In
general
(aa) The
Administrator shall designate as a substance likely to meet the safety standard
any new chemical substance that the Administrator determines, based on
available information, would likely meet the safety standard under section
6(d)—
(AA) for uses and
under conditions specified by the submitter of the notice for the new chemical
substance pursuant to paragraph (1); or
(BB) for uses and
under additional conditions that could be specified by the Administrator in
making a safety standard determination for the substance.
(bb) The
Administrator shall assign to the category described in item (aa) any new
chemical substance that meets the criteria specified in subclause (II) or
(III).
(II)
Substances of
very low concern
(aa)
In
general
Within the category described in subclause (I), the
Administrator shall designate as a substance of very low concern any new
chemical substance that, based on robust information, the Administrator
determines possesses intrinsic low-hazard properties so that no further action
by the Administrator is warranted unless and until the Administrator receives
new information that warrants a different categorization of the chemical
substance.
(bb)
Basis of
designation
In identifying new chemical substances to be placed
in the category described in this subclause, the Administrator shall base the
designation of a new chemical substance as a substance of very low concern on
the applicable minimum information set required under section 4, unless the
Administrator determines that such designation of a particular new chemical
substance—
(AA) can be made to a
high degree of confidence based on less information; or
(BB) requires
information in addition to the full minimum information set to address
conflicting or ambiguous findings, in which case the Administrator may require
the development and submission of the additional information.
(III)
Substances to
undergo safety standard determinations
Within the category
described in subclause (I), the Administrator shall designate as a substance to
undergo a safety standard determination any new chemical substance that the
Administrator determines, based on a screening of available use, hazard, and
exposure information, has information available for the chemical substance that
is sufficiently robust to determine that the chemical substance does not meet
the criteria for the categories described in subclause (II) or clause (ii) or
(iv).
(IV)
Requirement
For
a new chemical substance designated as likely to meet the safety standard
pursuant to subclause (II) or (III), the Administrator shall, upon submission
of a notice of commencement described in subsection (d)—
(aa) add the chemical
substance to the active inventory described in section 8(h)(1); and
(bb) for a chemical
substance designated to undergo a safety standard determination, at the
discretion of the Administrator accounting for timing of the submission and
workload considerations, add the chemical substance to the current batch or
hold the substance until the next batch of substances to be prioritized in
accordance with section 6(b)(4).
(V)
Manufacturing
and processing
Pending the completion of a safety standard
determination under section 6(d), a chemical substance designated as a
substance likely to meet the safety standard may be manufactured or processed
for uses and under conditions specified by the Administrator in determining
that the chemical substance is likely to meet the safety standard—
(aa) by
the submitter of the notice for the chemical substance submitted pursuant to
paragraph (1)(A), upon submission of a notice for the chemical substance
pursuant to subsection (d);
(bb) by
other manufacturers of the chemical substance, once the chemical substance has
been placed on the active inventory described in section 8(h)(1), upon
submission of a declaration for the chemical substance pursuant to section
8(b)(1)(B); or
(cc) by
processors of the substance, upon compliance with the requirements of section
8(e).
(iv)
Substances
with insufficient information
(I)
In
general
The Administrator shall designate as a substance with
insufficient information any new chemical substance for which the Administrator
concludes, after gathering and screening available use, hazard, and exposure
information, that needed information for the chemical substance is not
available, is insufficient, or is not of sufficient quality and reliability to
allow for an informed categorization decision.
(II)
Required
submission
For substances designated under this clause, the
Administrator shall require submission of the applicable minimum information
set specified under section 4 as needed to inform categorization decisionmaking
for new chemical substances.
(III)
Recategorization
Following
submission of the applicable minimum information set for the chemical substance
pursuant to subclause (II), the Administrator shall recategorize the chemical
substance using the categories and process described in this paragraph.
(IV)
Prohibition
Notwithstanding
paragraph (1)(C)(ii), no person may manufacture or process a chemical substance
designated under this clause until and unless the information described in
subclause (II) has been submitted and the Administrator has recategorized the
substance, at which time the provisions applicable to the category to which the
substance has been assigned shall apply.
(v)
Substances
unlikely to meet the safety standard
(I)
In
general
The Administrator shall designate as a substance unlikely
to meet the safety standard any new chemical substance that the Administrator
determines, based on available information, would be unlikely to meet the
safety standard under section 6(d)—
(aa) for uses and
under conditions specified by the submitter of the notice for the chemical
substance pursuant to paragraph (1); or
(bb) for other uses
or under additional conditions that the Administrator may evaluate in making a
safety standard determination for the chemical substance.
(II)
Prohibition
Except
as provided under clause (ii), no person may manufacture or process a chemical
substance designated under this clause.
(c)
New uses of
existing chemical substances
(1)
New uses of
existing chemical substances prior to safety standard determination
(A)
In
general
Except as provided in subparagraph (B), with respect to
an existing chemical substance for which the Administrator has not made a
safety standard determination under section 6(d), no person may manufacture or
process the chemical substance—
(i) for a use that
was not ongoing on the date of enactment of the
Safe Chemicals Act of 2013;
or
(ii) at a volume that
is significantly increased from the volume as of the date of enactment of the
Safe Chemicals Act of
2013.
(B)
Exception
A
person may manufacture or process a chemical substance in a manner prohibited
by subparagraph (A) if—
(i) the person
submits to the Administrator the notice specified in subsection
(g)(1)(B);
(ii) the person
complies with subsection (f); and
(iii) such
manufacturing or processing is consistent with subsection
(b)(2)(D)(iii)(V).
(C)
Guidance
Not
later than 90 days after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall issue guidance for the purpose of identifying what
constitute new uses and significantly increased production volumes under this
paragraph.
(2)
New uses of
existing chemical substances that meet the safety standard
(A)
In
general
For an existing chemical substance for which the
Administrator has determined under section 6(d) that the manufacturers and
processors of the chemical substance have established that the substance meets
the applicable safety standard, no person may manufacture, process, distribute
in commerce, use, or dispose of the chemical substance, or a mixture or article
containing the chemical substance for uses, at production volumes, or in
manners other than those the Administrator specified in the safety standard
determination, unless—
(i) the person
submits to the Administrator a notice in accordance with subsection (g)(1)(C)
of the intention of the person to manufacture, process, distribute in commerce,
use, or dispose of the chemical substance, or a mixture or article containing
the chemical substance, for the new use or at a new production volume, or in
such other manner that is inconsistent with a specified condition or term in
the safety standard determination made by the Administrator for that substance;
and
(ii) the
Administrator determines that the person submitting the notice has established
that the chemical substance will continue to meet the safety standard if the
allowed uses, production volumes, or other specified conditions or terms for
that substance, are revised to encompass the new use, new production volume, or
other manner of manufacturing, processing, distribution in commerce, use, or
disposal.
(B)
Amendment to
safety standard determination
If the conditions described in
clauses (i) and (ii) of subparagraph (A) are satisfied, the Administrator
shall, by order, amend the safety standard determination for the chemical
substance to include the new use, production volume, or other manner of
manufacturing or processing among the allowed uses, production volumes, or
manners of manufacturing, processing, distribution in commerce, use, or
disposal of the chemical substance.
(C)
Safety standard
determination
(i)
In
general
Except as provided in clauses (ii) and (iii), not later
than 180 days after the date of receipt of a notice pursuant to subparagraph
(A)(i), the Administrator shall determine whether the person submitting the
notice has established that the chemical substance will continue to meet the
safety standard under section 6(d).
(ii)
Extension
The
Administrator may extend the determination deadline under clause (i) by 1 or
more additional periods not to exceed 1 year in the aggregate, in such manner
as the Administrator determines necessary.
(iii)
Failure to
make a timely determination
The failure of the Administrator to
make a timely determination in accordance with this paragraph shall not be
sufficient to satisfy subparagraph (A)(ii).
(d)
Notice of
commencement
(1)
In
general
Not later than 30 days after the date on which a
manufacturer or processor commences manufacturing or processing of a new
chemical substance, the manufacturer or processor shall submit to the
Administrator a notice of commencement of manufacture or processing.
(2)
Requirements
The
notice of commencement shall—
(A) be considered
equivalent to the declaration required under subparagraph (A) or (C) of section
8(b)(2); and
(B) include the
information described in section 8(b)(5).
(3)
Withdrawal
A
person who has submitted a notice for a chemical substance under subsection (b)
or (c), and has not commenced with manufacture or processing of the substance,
may withdraw the notice.
(e)
Chemical
substances exhibiting special substance characteristics
(1)
Determination
The
Administrator shall determine by order or rule that a variant of a chemical
substance exhibiting 1 or more special substance characteristics—
(A) is a use that is
separate from any use of the chemical substance that does not exhibit the
special substance characteristics; or
(B) is a distinct
chemical substance.
(2)
Requirements
for variants that are separate uses
In the case of a chemical
substance that the Administrator determines to be a separate use based on the
special substance characteristics of the chemical substance, the manufacturer
or processor shall satisfy such further conditions as the Administrator
establishes, by order or rule.
(3)
Requirements
for variants that are distinct chemical substances
In the case of
a chemical substance that the Administrator determines to be a distinct
chemical substance based on the special substance characteristics of the
chemical substance, and that is not listed on the active inventory established
under section 8(h)(1), the manufacturer or processor shall comply with the
requirements of subsection (b).
(f)
Submission of
data
(1)
In
general
A person shall submit to the Administrator data in
accordance with the rule or order at the time that notice is submitted under
subsection (b) or (c) if the person is required to submit to the
Administrator—
(A) under subsection
(b) or (c), a notice prior to beginning the manufacture or processing of a
chemical substance; and
(B) under section
4(b), test data for the chemical substance prior to the submission of the
notice.
(2)
Availability
Subject
to section 14, the Administrator shall make any test data submitted under
paragraph (1) available on a publicly accessible Internet site.
(3)
Timing
Except
as provided under subsection (b)(2)(D)(iv), the Administrator may require a
person subject to an information requirement for a chemical substance under
this subsection or section 4 to submit the information—
(A) prior to and as a
condition of the Administrator assigning the substance to a category;
(B) as a condition of
commencement of manufacture or processing; or
(C) as a condition of
exceeding a specified manufacturing volume or expanding use of the
substance.
(g)
Content and
availability of notice
(1)
Content
(A)
New chemical
substances
A notice under subsection (b)(1) shall include—
(i) the chemical
identity and any special substance characteristics of the chemical
substance;
(ii) the identity and
primary business location of the manufacturer;
(iii) the information
described in section 8(h)(5)(B)(ii);
(iv) the minimum
information set described in section 4(a), where applicable; and
(v) a
statement that—
(I) the new chemical
substance is likely to meet the safety standard under section 6(d); or
(II) the 1 or more
uses proposed for the new chemical substance meet the criteria described in
section 6(h)(2)(B).
(B)
New uses of
existing chemical substances prior to safety standard
determination
A notice under subsection (c)(1) shall include all
updates to the declaration described in section 8(b)(2) and information
described in section 8(h)(5)(B)(ii) that is relevant to the new use, new
production volume, or other new manner of manufacturing or processing.
(C)
New uses of
existing chemical substances that meet the safety standard
A
notice under subsection (c)(2) shall include—
(i) all updates to
the declaration described in section 8(b)(2);
(ii) information
described in section 8(h)(5)(B)(ii) that is relevant to the new use, new
production volume, or other new manner of manufacturing or processing;
(iii) all updates to
the minimum information set described in section 4(a) relevant to the new use,
new production volume, or other new manner of manufacturing or processing;
and
(iv) a statement that
the chemical substance will continue to meet the safety standard if the allowed
uses, production volumes, or other specified conditions or terms for that
chemical substance are revised to encompass the new use, production volume, or
other manner of manufacturing or processing.
(2)
Availability
Subject
to section 14, the Administrator shall make the notices under paragraph (1)
available on a publicly accessible Internet site.
(3)
Public
information
Subject to section 14, not later than 5 days
(excluding Saturdays, Sundays, and legal holidays) after the date of the
receipt of a notice under subsection (b), (c), or (d), or of data under
subsection (f), the Administrator shall make available on a publicly accessible
Internet site a notice that—
(A) identifies the
chemical substance for which notice or information has been received;
(B) lists the uses or
intended uses of the chemical substance;
(C) for substances
for which a notice is submitted under subsection (b)(1), is promptly updated to
specify the category to which the Administrator has assigned the substance
pursuant to subsection (b)(2) once the assignment has been made;
(D) in the case of
the receipt of data under subsection (f), describes—
(i) the nature of the
tests performed with respect to the chemical substance; and
(ii) any data that
were received under subsection (f) or a rule or order under section 4;
and
(E) references the
availability of the minimum information set, where applicable.
(4)
List of
notices
At the beginning of each month, the Administrator shall
make available on a publicly accessible Internet site a list of each chemical
substance for which a notice has been received under subsection (b), (c), or
(d).
(h)
Exemptions
(1)
Intrinsically
safe substances
(A)
Exemption
(i)
In
general
If the Administrator determines that scientific consensus
exists that the intrinsic properties of a new chemical substance are such that
the chemical substance does not and would not pose any risk of injury to human
health or the environment under any intended or reasonably anticipated levels
of production, patterns of use, or exposures arising at any stage across the
lifecycle of the chemical substance, the Administrator may, by order, exempt
the chemical substance, or particular uses of such substances, from 1 or more
of the requirements of this section.
(ii)
Basis of
determination
A determination under clause (i)—
(I) shall be based on
consideration of the intrinsic properties of the chemical substance; and
(II) shall not be
based on findings or assumptions of low human or environmental exposure to such
substances.
(B)
Notice of
determination and exemption
Not later than 30 days after
providing an exemption pursuant to subparagraph (A), the Administrator shall
publish in the Federal Register a notice that—
(i) subject to
section 14, provides the specific identity of the chemical substance or
category;
(ii) if a particular
use of the chemical substance is exempted under subparagraph (A), describes the
particular use of the chemical substance that the Administrator has exempted;
and
(iii) explains and
documents the basis for the determination and exemption of the
Administrator.
(C)
Reconsideration
of exemption
(i)
In
general
The Administrator may reconsider and revoke or modify any
exemption provided under subparagraph (A) at any time if the Administrator
determines that—
(I) the conditions
specified in subparagraph (A) are no longer met; or
(II) such action is
necessary to protect human health or the environment or is otherwise in the
public interest.
(ii)
Publication
In
the event of a revocation or modification under clause (i), the Administrator
shall publish a notice of the grounds for the revocation.
(D)
Prior
regulatory exemptions
(i)
Review
(I)
In
general
Not later than 180 days after the date of enactment of
the Safe Chemicals Act of 2013,
the Administrator shall review exemptions that were granted pursuant to
subsection (h)(4) of this section as in effect on the day before that date of
enactment.
(II)
Effect of
exemption
An exemption described in subclause (I) shall continue
to be in effect until the date on which the Administrator determines, by order,
that—
(aa) the exemption is
not appropriate under this section, at which time the exemption shall cease to
be in effect; or
(bb) the exemption is
appropriate under this section, at which time the Administrator may issue an
order to modify or continue in effect the exemption pursuant to subparagraph
(A).
(ii)
Polymeric
chemical substances
Notwithstanding subparagraph (A) and any
previously issued exemption applicable to polymeric chemical substances—
(I) subsection (d)
shall apply to new polymeric chemical substances eligible for the previously
issued exemption—
(aa) during the
period prior to a determination by the Administrator pursuant to clause (i)
applicable to such substances; and
(bb) after a
determination by the Administrator pursuant to clause (i)(II)(bb) that
continuation of the prior exemption is appropriate for some or all such
substances, for such substances to which the continuation applies; and
(II) all of this
section shall apply to new polymeric chemical substances eligible for the
previously issued exemption after a determination by the Administrator pursuant
to clause (i)(II)(aa) that continuation of the prior exemption is not
appropriate for some or all such substances, for such substances to which the
determination applies.
(E)
No limitation
on authority
Nothing in this paragraph limits or otherwise
affects the authority of the Administrator under any other provision of this
Act.
(2)
Test marketing
purposes
Subject to paragraph (6), the Administrator may, upon
application, exempt any person from any requirement of subsection (b), (c), or
(f) to permit the person to manufacture or process a chemical substance for
test marketing purposes—
(A) upon a showing by
the person, in a manner that the Administrator determines, that the
manufacture, processing, distribution in commerce, use, and disposal of the
chemical substance (including any combination of those activities) will not
endanger human health or the environment; and
(B) under such
restrictions as the Administrator considers appropriate.
(3)
Equivalent
chemical substances
(A)
In
general
The Administrator shall, upon application, fully or
partially exempt any person from the requirement to submit any data under
subsection (b) or (f) if, on receipt of an application, the Administrator
determines that—
(i) the chemical
substance for which the application was submitted is equivalent to a chemical
substance for which data has been submitted to the Administrator as required by
this Act; and
(ii) submission of
data by the applicant on the chemical substance would be duplicative of data
which has been submitted to the Administrator in accordance with this
Act.
(B)
Effective
date
No exemption under this paragraph may take effect before the
beginning of the reimbursement period applicable to the data.
(C)
Fair and
equitable reimbursement
(i)
Definition of
reimbursement period
In this subparagraph, the term
reimbursement period, with respect to any previously submitted
data for a chemical substance, means a period—
(I) beginning on the
date of the termination of the prohibition, imposed under this section, on the
manufacture or processing of the chemical substance by the person who submitted
the data to the Administrator; and
(II) ending on the
later of—
(aa) the date that is
5 years after the date referred to in subclause (I); or
(bb) the expiration
of the period, which begins on the date referred to in subclause (I) and is
equal to the period that the Administrator determines to be necessary to
develop the data.
(ii)
Reimbursement
Except
as provided in clause (iii), if the Administrator exempts any person, under
subparagraph (A), and the exemption is granted during the reimbursement period
for that data, the Administrator shall order the person granted the exemption
to provide fair and equitable reimbursement (in an amount determined by the
Administrator)—
(I) to the person who
previously submitted the data on which the exemption was based, for a portion
of the costs incurred by the person in complying with the requirement under
this title to submit the data; and
(II) to any other
person who has been required under this subparagraph to contribute with respect
to the costs, for a portion of the amount the person was required to
contribute.
(iii)
Exception
Clause
(ii) shall not apply if the person exempted under that clause and the persons
described in subclauses (I) and (II) of that clause agree on the amount and
method of reimbursement.
(iv)
Considerations
In
promulgating rules for the determination of fair and equitable reimbursement to
the persons described in subclauses (I) and (II) of clause (ii) for costs
incurred with respect to a chemical substance, the Administrator shall, after
consultation with the Attorney General and the Federal Trade Commission,
consider all relevant factors, including—
(I) the effect on the
competitive position of the person required to provide reimbursement in
relation to the persons to be reimbursed; and
(II) the share of the
market for the chemical substance of the person required to provide
reimbursement to the share of the market of the persons to be
reimbursed.
(4)
Small
quantities solely for experimentation, research, and analysis
(A)
In
general
If the conditions described in subparagraph (B) are met,
subsections (b), (c), and (f) shall not apply with respect to the manufacturing
or processing of any chemical substance that is manufactured or processed, or
proposed to be manufactured or processed, only in small quantities (as defined
by the Administrator by rule) solely for purposes of—
(i) scientific
experimentation or analysis; or
(ii) chemical
research on, or analysis of the chemical substance or another chemical
substance, including such research or analysis for the development of a
product.
(B)
Conditions
All
persons engaged in the experimentation, research, or analysis for a
manufacturer or processor shall be notified (in such form and manner as the
Administrator may prescribe) of any risk to human health that the manufacturer,
processor, or the Administrator has reason to believe may be associated with
that chemical substance.
(5)
Temporary
existence
Subject to paragraph (6), the Administrator may, upon
application, exempt from subsections (b), (c), and (f) the manufacturing or
processing of any chemical substance—
(A) that exists
temporarily as a result of a chemical reaction in the manufacturing or
processing of a mixture or another chemical substance; and
(B) to which there is
no, and will not be, human or environmental exposure.
(6)
Publication
(A)
In
general
As soon as practicable after the date of receipt of an
application under paragraph (2) or (5), the Administrator shall publish in the
Federal Register notice of the receipt of the application.
(B)
Requirements
The
Administrator shall—
(i) give interested
persons an opportunity to comment upon any application described in
subparagraph (A);
(ii) not later than
45 days after the date of receipt of an application, approve or deny the
application; and
(iii) publish in the
Federal Register notice of the approval or denial of the application.
(i)
Certification
Each
submission required under this section or under a rule or an order promulgated
or issued by the Administrator under this section shall be accompanied by a
certification signed by a responsible official of the manufacturer or processor
that each statement contained in the submission—
(1) is accurate and
reliable; and
(2) includes all
material facts required by the applicable provision of this section or rule or
order under this
section.
.
7.
Batching,
categorization, prioritization, safety standard determination, and risk
management
(a)
In
general
Section 6 of the
Toxic Substances Control Act (15 U.S.C. 2605) is amended—
(1) by striking
subsection (f);
(2) by redesignating
subsection (e) as subsection (i);
(3) by striking the section heading and
designation and all that follows through subsection (d) and inserting the
following:
6.
Batching,
categorization, prioritization, safety standard determination, and risk
management
(a)
Batching
(1)
In
general
To ensure that an efficient and orderly process and pace
is established for the determination of safety of chemical substances in
commerce and the application of risk management measures as needed, the
Administrator shall establish a system for assigning chemical substances into
batches in accordance with this subsection.
(2)
Requirements
(A)
Timing
Not
later than 270 days after the date of enactment of the
Safe Chemicals Act of 2013, and
not less frequently than once every 5 years thereafter until all chemical
substances listed on the active portion of the inventory established under
section 8(h)(1) have been assigned to a batch, the Administrator shall assign
chemical substances on the active portion of the inventory to batches of
chemical substances under this subsection.
(B)
Number
Each
batch established under this subsection shall include a number of chemical
substances approximately equal to the number of chemical substances for which
reports are submitted to the Administrator under the chemical data reporting
rule as of the date of enactment of the Safe
Chemicals Act of 2013.
(C)
Publication
The
Administrator shall publish, subject to section 14, the list of chemical
substances assigned to each batch promptly on designation of the chemical
substances to the batch.
(3)
Initial
batch
(A)
In
general
Subject to subparagraph (B), the initial batch of
chemical substances designated under paragraph (2)(A) shall include the
chemical substances for which reports are submitted to the Administrator under
the chemical data reporting rule as of the date of enactment of the
Safe Chemicals Act of
2013.
(B)
Inclusions and
exclusions
Notwithstanding subparagraph (A), the Administrator
may—
(i) include in the
initial batch chemical substances that—
(I) are manufactured
at volumes below the threshold used under the chemical data reporting rule to
designate chemical substances subject to basic reporting under that rule;
but
(II) are used or
released into the environment in a manner that the Administrator determines
warrants early evaluation; and
(ii) exclude from the
initial batch chemical substances that—
(I) are reported to
the Administrator under the chemical data reporting rule; but
(II) are used or
released into the environment in a manner that the Administrator determines
does not warrant early evaluation.
(4)
Subsequent
batches
The Administrator shall assign chemical substances to
subsequent batches in a manner that the Administrator determines reflects the
extent to which the chemical substances warrant earlier or later
evaluation.
(b)
Categorization
and prioritization
(1)
Regulations
Not
later than 1 year after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall promulgate regulations that—
(A) establish the
categories and specify the process and criteria the Administrator will use to
categorize chemical substances, which shall be consistent with paragraph
(3)(B), beginning with those chemical substances assigned to the initial batch
described in subsection (a)(3);
(B) designate the
process and criteria the Administrator will use to prioritize chemical
substances that are placed in the category of chemical substances to undergo
safety standard determinations, which shall be consistent with the priorities
described in paragraph (4);
(C) describe how the
categorization and prioritization process and criteria relate to, and take into
account, the categorization and prioritization decisions made in other
jurisdictions, including States and foreign governments; and
(D) describe criteria
and factors the Administrator will use to weigh evidence and assess the quality
and reliability of information used to inform categorization and prioritization
decisions.
(2)
Information
sources
(A)
In
general
In making categorization and prioritization decisions,
the Administrator shall take into consideration information regarding chemical
substances that is available to the Administrator at the time the decisions are
made, including information that is—
(i) received by the
Administrator from manufacturers or processors pursuant to requirements under
section 8(b) and (c);
(ii) included in any
minimum information set required under section 4;
(iii) submitted to
the Administrator that is relevant to the categorization or prioritization of
the chemical substance; and
(iv) identified
through an active search by the Administrator of information sources that are
publicly available or otherwise accessible to the Administrator.
(B)
Information
from manufacturers and processors
(i)
In
general
Subject to clause (ii), on designation by the
Administrator under paragraph (3)(B)(iii) of a chemical substance safety
standard determination, any manufacturer or processor of a designated chemical
substance and any trade association or voluntary consortium that represents a
manufacturer or processor of a designated chemical substance may provide to the
Administrator information that—
(I) relates to the
chemical substances manufactured or processed by the applicable manufacturer or
processor;
(II) is in the
possession of, or known to, the manufacturer, processor, trade association, or
consortium; and
(III) is not already
available to the Administrator.
(ii)
Requirement
If
a manufacturer, processor, trade association, or consortium elects to provide
information to the Administrator under clause (i), the manufacturer, processor,
trade association, or consortium shall provide all relevant information in the
possession of, or known to, the manufacturer, processor, trade association, or
consortium for each chemical substance designated by the Administrator that is
manufactured or processed by the applicable manufacturer or processor.
(iii)
Method of
submission
Information described in this subparagraph may be
submitted to the Administrator by—
(I) a manufacturer or
processor—
(aa) on
an individual basis; or
(bb) through a trade
association or voluntary consortium; and
(II) a trade
association or voluntary consortium that has developed relevant information on
behalf of the manufacturers or processors of designated chemical substances
represented by the trade association or voluntary consortium.
(3)
Categorization
of chemical substances
(A)
Timing
(i)
Initial
batch
Not later than 180 days after the date of promulgation of
regulations pursuant to paragraph (1), the Administrator shall publish, subject
to section 14, the category assignments for the initial batch of chemical
substances identified under subsection (a)(3), using the categories described
in subparagraph (B).
(ii)
Subsequent
batches
Not later than 180 days after the date on which the
Administrator designates each subsequent batch of chemical substances under
subsection (a)(2)(A), the Administrator shall publish the category assignments
for the chemical substances in the batch.
(B)
Categories
The
regulation promulgated pursuant to paragraph (1) shall incorporate, establish
criteria for, and further specify as needed, the following categories into
which chemical substances in each batch shall be placed:
(i)
Substances of
very high concern
(I)
In
general
The Administrator shall designate as substances of very
high concern those chemical substances—
(aa) for which there
is evidence of widespread exposure and that—
(AA) are toxic,
persist in the environment, and are bioaccumulative; or
(BB) are highly
hazardous; or
(bb) that are subject
to regulation under section 6 or 7 of this Act (as in effect on the day before
the date of enactment of the Safe Chemicals
Act of 2013).
(II)
Information
set
A minimum information set, as specified under section 4, need
not be submitted or otherwise available for a chemical substance to be
designated a substance of very high concern under this clause.
(ii)
Substances of
very low concern
(I)
In
general
The Administrator shall designate as substances of very
low concern those chemical substances that, based on robust information, the
Administrator determines possess intrinsic low-hazard properties such that no
further action by the Administrator is warranted, unless the Administrator
receives new information that warrants a different categorization of the
chemical substance.
(II)
Factors for
consideration
In designating chemical substances to be placed in
the very low concern category under this clause, the Administrator
shall—
(aa) take into
consideration whether chemical substances in commerce have received, as of the
date of enactment of the Safe Chemicals Act
of 2013, exemptions under section 5 of this Act (as in effect on
the day before the date of enactment of the Safe Chemicals Act of 2013) based on
anticipated low intrinsic hazard; and
(bb) in
general, base the designation on a minimum information set as required under
section 4, unless the Administrator determines that such designation of a
particular chemical substance—
(AA) can be made to a
high degree of confidence based on less information; or
(BB) requires
information in addition to the full minimum information set to address
conflicting or ambiguous findings, in which case the Administrator may require
the development and submission of the additional information.
(iii)
Substances to
undergo safety standard determinations
The Administrator shall
designate as substances to undergo safety standard determinations those
chemical substances that the Administrator determines—
(I) based on a
screening of available use, hazard, and exposure information, do not meet the
criteria for the categories described in clauses (i) and (ii); and
(II) are the subject
of available information that is sufficiently robust to inform prioritization
decisions to be made for the chemical substances under paragraph (4).
(iv)
Substances
with insufficient information
(I)
In
general
The Administrator shall designate as substances with
insufficient information those chemical substances for which the Administrator
determines, after gathering and screening available use, hazard, and exposure
information, that information is not available, is insufficient, or is not of
sufficient quality and reliability to allow for an informed categorization
decision.
(II)
Minimum
information set
(aa)
In
general
For chemical substances designated under this clause, the
Administrator shall require submission of the applicable minimum information
set specified under section 4 as needed to inform categorization
decisionmaking.
(bb)
Timing
The
minimum information set shall be submitted to the Administrator—
(AA) not later than 5
years after the date of enactment of the Safe
Chemicals Act of 2013 for the initial batch of chemical
substances identified under subsection (a)(3); and
(BB) not later than 5
years after the assignment of a chemical substance to the category under this
clause for subsequent batches.
(III)
Recategorization
(aa)
In
general
After submission of the minimum information set for a
chemical substance pursuant to subclause (I), the Administrator shall
recategorize the chemical substance using the categories and process described
in this paragraph.
(bb)
Discretion of
Administrator
The Administrator, taking into account the timing
of the submission and workload considerations, may—
(AA) add a chemical
substance to a current batch; or
(BB) hold the
chemical substance until the next batch of chemical substances for
recategorization.
(v)
Designation to
only 1 category
A chemical substance shall not be simultaneously
in more than 1 of the categories designated under clause (i) through
(iv).
(4)
Prioritization
of chemical substances
(A)
Timing
(i)
Initial
batch
Not later than 270 days after the date of promulgation of
regulations pursuant to paragraph (1), the Administrator shall publish, subject
to section 14, the priority class assignments, using the priority classes
described in subparagraph (B), for the chemical substances in the initial batch
of chemical substances identified under subsection (a)(3) that the
Administrator has assigned to the category of chemical substances to undergo
safety standard determinations.
(ii)
Subsequent
batches
Not later than 270 days after the date on which the
Administrator designates each subsequent batch of chemical substances under
subsection (a)(2)(A), the Administrator shall publish the priority class
assignments for the chemical substances in the batch that the Administrator has
assigned to the category of chemical substances to undergo safety standard
determinations.
(B)
Criteria
The
criteria used by the Administrator to assign chemical substances to priority
classes shall take into account—
(i) potential impacts
of the chemical substance on human health and the environment;
(ii) the hazard
potential of the chemical substance, including classifications and designations
of hazard characteristics by other authoritative entities;
(iii) the potential
for exposure to the chemical substance; and
(iv) measurements of
exposure for a given pathway of exposure, if available and reliable, in
preference to less direct indicators of, or surrogates for, exposure potential
for the same pathway.
(C)
Priority
classes
The regulations promulgated pursuant to paragraph (1)
shall establish the following priority classes and criteria, and further
specify the process the Administrator will use to assign to the priority
classes the chemical substances in each batch that the Administrator has
assigned to the category of chemical substances to undergo safety standard
determinations:
(i)
Priority Class
1
(I)
In
general
In each batch, the Administrator shall designate as
Priority Class 1 those chemical substances that the Administrator determines
warrant safety standard determinations in the near term.
(II)
Initial
assignment
The Administrator shall in each batch initially
designate as Priority Class 1 chemical substances that possess relatively
greater hazard potential and for which there is evidence of more significant or
widespread exposure.
(III)
Reassignment
As
safety standard determinations for the chemical substance are completed, the
Administrator may designate as Priority Class 1 any chemical substance
initially assigned to a lower priority class, including chemical
substances—
(aa) posing
significant hazard concerns but of less or unknown exposure concern;
(bb) posing
significant exposure concern but of less or unknown hazard concern; or
(cc) posing less
hazard and exposure concerns.
(IV)
Factors for
consideration
In determining the number of chemical substances to
be placed in Priority Class 1, the Administrator shall seek to balance
considerations relating to—
(aa) the number of
chemical substances for which safety standard determinations need to be
conducted;
(bb) the resources
available to the Administrator for conducting safety standard determinations;
and
(cc) the deadlines
for completion of safety standard determinations specified in subsection
(d)(4).
(ii)
Priority Class
2
(I)
In
general
The Administrator shall designate as Priority Class 2
those chemical substances that the Administrator determines are of lower
priority than Priority Class 1 substances with respect to the timing for
conducting safety standard determinations.
(II)
Minimum
information set
(aa)
In
general
For chemical substances designated under this clause, the
Administrator shall require submission of the applicable minimum information
set specified under section 4 as needed to inform prioritization
decisionmaking.
(bb)
Timing
The
minimum information set shall be submitted to the Administrator—
(AA) not later than 5
years after the date of enactment of the Safe
Chemicals Act of 2013 for chemical substances in the initial
batch identified under subsection (a)(3) that are assigned to Priority Class 2;
and
(BB) not later than 5
years after the assignment of a chemical substance to Priority Class 2 under
this clause for subsequent batches.
(III)
Reprioritization
After
submission of the minimum information set for a chemical substance under
subclause (II), the Administrator shall, if warranted, recategorize or
otherwise reprioritize the chemical substance using the priority classes and
process described in this paragraph, together with other chemical substances in
the batch undergoing prioritization at the time of the submission.
(IV)
Reprioritization
to Priority Class 1
As safety standard determinations are
completed on Priority Class 1 chemical substances pursuant to subsection (d),
the Administrator shall reprioritize Priority Class 2 substances as Priority
Class 1 at a pace consistent with—
(aa) the resources
available to the Administrator for conducting safety standard determinations;
and
(bb) the deadlines
for completion of safety standard determinations specified in subsection
(d)(4).
(iii)
Priority
Class 3
(I)
In
general
The Administrator shall designate as Priority Class 3
those chemical substances that the Administrator determines may be set aside
for further assessment until such time as—
(aa) safety standard
determinations are completed on all Priority Class 1 and 2 substances;
or
(bb) new information
arises that warrants reprioritization of such a substance to a higher priority
class.
(II)
Minimum
information set
(aa)
In
general
For a chemical substance designated under this clause,
the Administrator shall not require submission of the applicable minimum
information set specified under section 4 until such time as the chemical
substance is reassigned to Priority Class 1 or 2.
(bb)
Submission
On
reassignment of a chemical substance to Priority Class 1 or 2 under item (aa),
the minimum information set shall be submitted to the Administrator not later
than 5 years after the date of the reassignment.
(III)
Reprioritization
After
submission of the minimum information set for a chemical substance pursuant to
subclause (II), the Administrator shall reprioritize the chemical substance
using the priority classes and process described in this paragraph, together
with chemical substances in the batch undergoing prioritization at the time of
the submission.
(IV)
Reprioritization
to Priority Classes 1 and 2
In conjunction with the
reprioritization by the Administrator of Priority Class 2 substances as
Priority Class 1, the Administrator shall reprioritize Priority Class 3
substances as Priority Class 1 or 2, at a pace consistent with—
(aa) the resources
available to the Administrator for conducting safety standard determinations;
and
(bb) the deadlines
for completion of safety standard determinations specified in subsection
(d)(4).
(c)
Treatment as
final agency action; no judicial review; nondiscretionary duty
(1)
In
general
The designation by the Administrator of batches of
chemical substances pursuant to subsection (a), the assignment of chemical
substances to categories pursuant to subsection (b)(3), and the assignment of
chemical substances to priority classes pursuant to subsection (b)(4),
including any determination of the Administrator to include a specific chemical
substance in, or exclude a specific chemical substance from, a designated
batch, category, or priority class under this section, shall not be—
(A) considered to be
a final agency action for the purpose of subchapter II of chapter 5, and
chapter 7, of title 5, United States Code (commonly known as the
Administrative Procedure Act); or
(B) subject to
judicial review.
(2)
Failure to
act
A failure by the Administrator to designate or publish a list
of chemical substances assigned to a batch, category, or priority class in
accordance with this subsection shall be—
(A) considered to be
a failure to perform a nondiscretionary duty; and
(B) subject to
judicial review.
(d)
Safety standard
determinations for chemical substances
(1)
In
general
(A)
Application
This
paragraph applies to any determination or redetermination regarding whether a
chemical substance meets the safety standards of this Act.
(B)
Responsibilities
(i)
In
general
For purposes of this Act, each manufacturer and processor
of a chemical substance shall at all times bear the burden of proof in any
legal proceeding relating to a decision of the Administrator regarding whether
the chemical substance meets the safety standard.
(ii)
Duties
For
purposes of this Act—
(I) it shall be the
duty of the manufacturer or processor of a chemical substance to provide
sufficient information for the Administrator to determine whether the chemical
substance meets the safety standard; and
(II) it shall be the
duty of the Administrator to determine whether a chemical substance meets the
safety standard.
(2)
Assessment of
risk
(A)
Assessment
(i)
In
general
A chemical substance that undergoes a safety standard
determination under this section may be manufactured, processed, or distributed
in commerce only if the Administrator determines that the chemical
substance—
(I) meets the safety
standard, taking into account any existing conditions or controls already in
effect; or
(II) can meet the
safety standard for all or some uses through the imposition of additional
conditions.
(ii)
Requirement
Any
assessment of risk used to support a determination that a chemical substance
meets the safety standard under clause (i) shall be conducted by employees of
the Environmental Protection Agency who are competent to conduct such
assessments.
(B)
Safety
standard
(i)
In
general
The Administrator shall base a determination of whether a
safety standard for a chemical substance has been met under subparagraph (A)
solely on considerations of human health and the environment, including the
health of vulnerable populations.
(ii)
Considerations
In
making a safety standard determination under this subsection, for each chemical
substance, the Administrator shall—
(I) to the extent
practicable, review and incorporate any available scientific information
relating to the effect of cumulative exposure relevant to that chemical
substance on human health and the environment; and
(II) find that a
chemical substance meets the safety standard only if the Administrator finds
that there is a reasonable certainty that no harm will result to human health
or the environment from aggregate exposure to the chemical substance.
(C)
Financial
interests
No person conducting an assessment described in
subparagraph (A), or a peer review of such an assessment, may have a direct or
indirect financial interest in the outcome of the assessment.
(D)
Methodology
(i)
In
general
Subject to clause (ii), the Administrator shall use the
best available science when conducting an assessment described in subparagraph
(A).
(ii)
Considerations
For
the purpose of determining the current best available science the Administrator
shall base the determination on the recommendations of the National Academy of
Sciences in the report entitled Science and Decisions.
(iii)
Review
Not
later than 5 years after the date of enactment of the
Safe Chemicals Act of 2013, and
not less frequently than once every 5 years thereafter, the Administrator shall
review the methodology under this paragraph and may revise the methodology to
reflect new scientific developments or understandings.
(E)
Scope
An
assessment described in subparagraph (A) shall address health or environmental
impacts including potential or demonstrated cancer and noncancer
endpoints.
(F)
Transparency
In
carrying out this subsection, the Administrator shall ensure that the
approaches and resulting assessments are communicated in a manner that is
transparent and understandable to—
(i) the public;
and
(ii) risk
managers.
(G)
Manufacture or
processing for export
In the case of a chemical substance that is
manufactured or processed in whole or in part for export, in determining
whether the chemical substance meets the safety standard under subparagraph
(A)(i), the Administrator shall take into account any risk—
(i) that the chemical
substance may pose in the United States, including risks involving long-range
transport of the chemical substance in the environment; or
(ii) involving the
import of articles and mixtures containing the chemical substance.
(H)
Risk assessment
not required
The Administrator shall not be required to conduct a
risk assessment to determine that a manufacturer or processor has not met the
burden of proof under paragraph (1)(B).
(I)
No judicial
review
A determination by the Administrator that a manufacturer
or processor has not established that the chemical substance meets the
applicable safety standard under this subsection shall not be subject to
judicial review.
(3)
Information for
safety standard determinations
(A)
In
general
In making a safety standard determination with respect to
a chemical substance, the Administrator—
(i) shall take into
consideration information regarding the chemical substance that is already
available to the Administrator at the time the determination is to be made,
including information—
(I) received by the
Administrator from manufacturers or processors under this section or section
8;
(II) contained in any
minimum information sets previously required under section 4;
(III) voluntarily
submitted by manufacturers and processors in accordance with subsection
(b)(2)(B);
(IV) submitted by any
other party to the Administrator that is relevant to the conduct of a safety
standard determination of the chemical substance; or
(V) identified
through an active search by the Administrator of information sources that are
publicly available or otherwise accessible to the Administrator;
(ii) shall require
information needed to complete the applicable minimum information set for the
chemical substance required under section 4(a);
(iii) may require, by
regulation or order pursuant to section 4(b) or 8(e), manufacturers or
processors of the chemical substance to develop and submit any additional
information the Administrator determines is needed to conduct the safety
standard determination of the chemical substance; and
(iv) shall take into
consideration, but not rely on, assessments of safety or analyses of the
effectiveness of existing control measures—
(I) submitted to the
Administrator by any party; or
(II) conducted by a
governmental entity in another jurisdiction.
(4)
Timing of
safety standard determinations
(A)
Priority Class
1
(i)
In
general
Beginning with chemical substances initially designated
as Priority Class 1 under subsection (b)(4)(C)(i), the Administrator shall
conduct safety standard determinations of all chemical substances assigned to
the category of substances to undergo safety standard determinations pursuant
to subsection (b)(3)(B)(iii).
(ii)
Initial
batch
Not later than 5 years after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall complete and publish safety standard determinations for all
chemical substances designated as Priority Class 1 substances in the initial
batch of chemical substances identified under subsection (a)(3).
(iii)
Subsequent
batches
Not later than 5 years after the date on which the
Administrator designates chemical substances as Priority Class 1 in each
subsequent batch of chemical substances under subsection (a)(2)(A), the
Administrator shall complete and publish safety standard determinations for
those Priority Class 1 substances in the batch.
(B)
Priority
Classes 2 and 3
(i)
In
general
Each chemical substance initially designated as Priority
Class 2 or 3 shall become subject to reprioritization and safety standard
determinations in accordance with subsection (b)(4).
(ii)
Reprioritization
Not
later than 5 years after the date on which the Administrator designates a
Priority Class 2 or 3 substance to be Priority Class 1, the Administrator shall
complete and publish the safety standard determination on the chemical
substance.
(C)
Notice of
overdue determination
If the Administrator fails to act by an
applicable deadline under subparagraph (A) or (B), each manufacturer and
processor of a chemical substance for which the Administrator has failed to act
shall provide to the Administrator, the public, employees and recognized
bargaining agents of any employees who are represented by bargaining agents of
the manufacturer or processor, and each known customer who has purchased the
chemical substance within a reasonable timeframe, as determined by the
Administrator by regulation or order, a written notice that a determination by
the Administrator of the safety of the chemical substance is pending.
(D)
Failure of
manufacturer or processor to meet duties
If a manufacturer or
processor fails to meet any duty under this paragraph for a chemical substance,
the Administrator, by order, may take any action authorized under subsection
(f).
(5)
Outcome of
safety standard determinations
(A)
Determination
(i)
In
general
In making a safety standard determination for a chemical
substance, the Administrator, by order, shall determine or redetermine, as
appropriate, whether the manufacturers and processors of the chemical substance
have established that the chemical substance meets the safety standard.
(ii)
Concurrent
publication
The Administrator—
(I) shall seek to
publish safety standard determination and risk management decisions
concurrently, to the maximum extent practicable; but
(II) shall not unduly
delay the issuance of any safety standard determination if more information or
analysis is required to make a determination regarding risk management.
(iii)
Other
requirements
The Administrator—
(I) may publish
safety standard determinations for chemical substances individually or in
groups; but
(II) shall publish
completed determinations—
(aa) not less
frequently than annually; and
(bb) at
a pace sufficient to demonstrate steady progress toward completing all such
safety standard determinations within the required timeframe.
(iv)
Public notice
and comment
The Administrator shall provide reasonable public
notice and opportunity for comment on all published safety standard
determinations through any reasonable means of publication and solicitation of
comments, including electronic means.
(B)
Positive safety
standard determination without new conditions
If the
Administrator determines that a chemical substance meets the safety standard
for all current uses and under conditions currently used, the Administrator
shall specify in the order—
(i) the allowed uses
of the chemical substance, which shall be limited to the uses evaluated in the
determination; and
(ii) conditions on
the specified uses that are currently used and are to be followed to ensure the
safety standard is met, including conditions relating to the manufacture,
processing, use, distribution in commerce, or disposal of a chemical substance
or mixture or article containing the chemical substance.
(C)
Positive safety
standard determination with new conditions
If the Administrator
determines that a chemical substance can only meet the safety standard for a
subset of all current uses or only under conditions beyond those currently
used, the Administrator shall specify in the order—
(i) the allowed uses
of the chemical substance, which shall be limited to the uses evaluated in the
determination that the Administrator determines meet the safety standard;
and
(ii) all current and
all newly required conditions on the specified uses needed to ensure the safety
standard is met, including conditions relating to the manufacture, processing,
use, distribution in commerce, or disposal of a chemical substance or mixture
or article containing the chemical substance, and any conditions described in
subsection (f).
(D)
Effective date
for positive safety standard determination
(i)
Without new
conditions
Effective beginning on the date that is 90 days after
the date of a determination by the Administrator under subparagraph (B), no
person shall manufacture, process, or distribute in commerce the chemical
substance subject to the determination, or any mixture or article containing
the chemical substance, for any use or under any condition other than those
specified in the determination order.
(ii)
With new
conditions
Effective beginning on the date that is 18 months
after the date of a determination by the Administrator under subparagraph (C),
except as provided in clause (iii), no person shall manufacture, process, or
distribute in commerce the chemical substance subject to the determination, or
any mixture or article containing the chemical substance, for any use or under
any condition other than those specified in the determination order.
(iii)
Exceptional
circumstance
The Administrator may grant a manufacturer or
processor of a chemical substance a 1-time extension of the deadline for
complying with a restriction under clause (ii), for a period of not longer than
5 years after the date of the determination by the Administrator under
subparagraph (C), if the manufacturer or processor demonstrates—
(I) a compelling
technological need to continue a restricted activity beyond the applicable
18-month time period; or
(II) that a factor
wholly beyond the control of the manufacturer or processor prevents compliance
with the restriction within that 18-month time period.
(E)
Redetermination
(i)
In
general
The Administrator shall initiate a redetermination of
whether a chemical substance meets the safety standard if new information or
significant changes in manufacture, processing, use, or distribution in
commerce of the chemical substance, or mixtures or articles containing the
chemical substance, raise a credible question as to whether the chemical
substance continues to meet the safety standard.
(ii)
New
methodologies
The Administrator may initiate a redetermination of
whether a chemical substance meets the safety standard if significant changes
have occurred in the methodologies used in the initial safety standard
determination such that a redetermination using the newer methodologies would
provide a significantly improved determination of the safety of the chemical
substance.
(iii)
New
information
For a chemical substance for which a safety standard
determination has been completed, the Administrator shall assess, on an ongoing
basis, new information, including that obtained from reporting under section 8,
to decide whether such information raises a credible question as to whether a
chemical substance continues to meet the safety standard.
(iv)
Petition for
redetermination
(I)
In
general
Any person may petition the Administrator for a
redetermination of whether a chemical substance continues to meet the safety
standard.
(II)
Basis
A
person shall include in a petition under this clause a description of the basis
for requesting the redetermination.
(III)
Action by
Administrator
On receipt of a petition under this clause, the
Administrator shall—
(aa) not later than
30 days after the date of receipt, publish in the Federal Register a notice of
receipt of the petition that specifies the chemical identity of the chemical
substance to which the petition pertains;
(bb) make the
petition available on request;
(cc) provide a
reasonable opportunity for public review and comment on the petition and give
due consideration to any comments received;
(dd) decide whether
to make the requested redetermination; and
(ee) not later than
180 days after the date of receipt, publish in the Federal Register the
decision and the basis for the decision.
(v)
Deadline for
completion
Each redetermination carried out under this
subparagraph shall be completed by not later than 3 years after the date of the
decision to make the redetermination.
(F)
Negative safety
standard determination
(i)
Restriction
Except
as provided in clause (ii) and subsection (h), effective beginning on the date
that is 18 months after the date on which the Administrator makes a
determination under this subsection that a chemical substance fails to meet the
safety standard, regardless of whether additional restrictions on use or risk
management conditions are imposed, no person shall manufacture, process, or
distribute in commerce that chemical substance or any mixture or article
containing the chemical substance.
(ii)
Exceptional
circumstance
The Administrator may grant a manufacturer or
processor of a chemical substance a 1-time extension of the deadline for
complying with the restriction under clause (i), for a period of not longer
than 5 years after the date of the determination by the Administrator under
this subparagraph, if the manufacturer or processor demonstrates—
(I) a compelling
technological need to continue a restricted activity beyond the applicable
18-month time period; or
(II) that a factor
wholly beyond the control of the manufacturer or processor prevents compliance
with the restriction within that 18-month time period.
(e)
Expedited
action for substances of very high concern
(1)
Use and
exposure assessment
(A)
In
general
Not later than 180 days after the date on which a
chemical substance is assigned to the category of substances of very high
concern under subsection (b)(3)(B)(i), the Administrator may require, by order
pursuant to section 8(g), the submission by manufacturers or processors of the
chemical substance of any additional information the Administrator determines
to be necessary to conduct an expedited assessment of the known uses of, and
exposures to, the chemical substance.
(B)
Publication
Not
later than 1 year after the date on which a chemical substance is assigned to
the category of substances of very high concern under subsection (b)(3)(B)(i),
the Administrator shall complete and publish an identification and assessment
of the known uses of, and exposures to, the chemical substance.
(2)
Exposure
reduction
(A)
Use
restrictions and other conditions
As soon as practicable, but not
later than 18 months, after the date on which a chemical substance is assigned
to the category of substances of very high concern under subsection
(b)(3)(B)(i), the Administrator shall impose, by order, use restrictions and
other conditions, including the conditions specified in subsection (f), on the
manufacturing, processing, use, distribution in commerce, and disposal of the
chemical substance that the Administrator determines to be necessary to achieve
the maximum practicable reduction in human or environmental exposure to the
chemical substance.
(B)
Timing
Except
as provided in subparagraph (C) and subsection (h), effective beginning on the
date that is 18 months after the date of issuance by the Administrator of the
order described in subparagraph (A), no person shall manufacture, process, or
distribute in commerce the chemical substance subject to the determination, or
any mixture or article containing the chemical substance, for any use or under
any condition other than those specified in the order issued under subparagraph
(A).
(C)
Exceptional
circumstance
The Administrator may grant a manufacturer or
processor of a chemical substance a 1-time extension of the deadline for
complying with the restriction under subparagraph (B), for a period of not
longer than 5 years after the date of the determination by the Administrator
under this paragraph, if the manufacturer or processor demonstrates—
(i) a
compelling technological need to continue a restricted activity beyond the
applicable 18-month time period; or
(ii) that a factor
wholly beyond the control of the manufacturer or processor prevents compliance
with the restriction within that 18-month time period.
(3)
Residual risk
assessment
Not later than 1 year after the deadline specified in
paragraph (2)(B), or of an alternative deadline provided under paragraph
(2)(C), the Administrator shall—
(A) determine whether
the chemical substance meets the safety standard for the chemical substance,
taking into account the residual risk posed by continued exposure to the
chemical substance; and
(B) impose any
additional restrictions on use or other conditions under subsection (f) that
the Administrator determines to be necessary to ensure that the chemical
substance meets the safety standard.
(f)
Risk
management
In issuing an order under subsection (d) or (e), the
Administrator may impose conditions on the manufacture, processing, use,
distribution in commerce, or disposal of a chemical substance, or mixture or
article containing a chemical substance, including a requirement—
(1) limiting the
quantity of the chemical substance (or mixture or article containing that
chemical substance) that may be manufactured, processed, or distributed in
commerce;
(2)
(A) prohibiting the
manufacturing, processing, or distribution in commerce of the chemical
substance (or mixture or article containing that chemical substance) for a
particular use in a concentration in excess of a level specified by the
Administrator; or
(B) limiting the quantity of the chemical
substance (or mixture or article containing that chemical substance) that may
be manufactured, processed, or distributed in commerce for—
(i) a particular use; or
(ii) a particular use in a
concentration in excess of a level specified by the Administrator;
(3) that the chemical
substance (or mixture, or article containing that chemical substance) be marked
with, or accompanied by, clear and adequate warnings and instructions with
respect to use, distribution in commerce, or disposal, or any combination of
such activities, with the form and content of the warnings and instructions
prescribed by the Administrator;
(4) that
manufacturers and processors of the chemical substance (or mixture or article
containing that chemical substance)—
(A) make and retain
records of the processes used to manufacture or process the chemical substance
(or mixture or article containing that chemical substance); and
(B) monitor or
conduct tests that are reasonable and necessary to ensure compliance with this
Act;
(5) prohibiting or
otherwise regulating any manner or method of commercial use of the chemical
substance (or mixture or article containing that chemical substance);
(6) prohibiting or
otherwise regulating any manner or method of disposal of the chemical
substance, mixture, or article, by—
(A) the manufacturer
or processor of the chemical substance (or mixture or article containing that
chemical substance); or
(B) any other person
that uses or disposes of the chemical substance (or mixture or article
containing that chemical substance) for commercial purposes;
(7) that the
manufacturers and processors of the chemical substance, mixture, or article
develop a risk reduction management plan, under subsection (h) or (e) of this
section, to achieve a risk reduction specified by the Administrator; or
(8) that the
Administrator otherwise determines is appropriate.
(g)
Quality control
orders
(1)
In
general
If the Administrator has a reasonable basis to conclude
that a particular manufacturer or processor is manufacturing or processing a
chemical substance in a manner that may present a substantial endangerment to
health or the environment, the Administrator may require, by order, that the
manufacturer or processor submit to the Administrator a description of the
quality control procedures followed in the manufacturing or processing of the
chemical substance or mixture.
(2)
Orders
(A)
In
general
If the Administrator determines that quality control
procedures described in paragraph (1) are inadequate to prevent a chemical
substance from presenting a risk of injury to human health or the environment,
the Administrator may order the manufacturer or processor to revise the quality
control procedures to the extent necessary to remedy the inadequacy.
(B)
Substantial
endangerment
If the Administrator determines that quality control
procedures described in paragraph (1) have resulted in the distribution in
commerce of a chemical substance that may present a substantial endangerment to
human health or the environment, the Administrator may order the manufacturer
or processor—
(i) to give notice of
the endangerment to—
(I) processors or
distributors (or both) in commerce of the chemical substance or mixture;
and
(II) to the extent
reasonably ascertainable, any other person in possession of or exposed to the
chemical substance or mixture;
(ii) to give public
notice of the endangerment; and
(iii) to provide for
the replacement or repurchase, as prescribed by the Administrator, of the
chemical substance as the Administrator determines to be necessary to
adequately protect human health or the environment.
(h)
Exemptions to
restrictions
(1)
Application
This
subsection applies to the restrictions established under section
5(b)(1)(C)(ii)(I), subsection (d)(5), and subsections (e) and (f).
(2)
Exemptions
(A)
In
general
(i)
Request
A
person who manufacturers, processes, distributes in commerce, uses, or disposes
of a chemical substance, or a mixture or article containing a chemical
substance may request an exemption from any restriction referred to in
paragraph (1) to which they are subject for a specified use of the chemical
substance.
(ii)
Order
The
Administrator may grant, by order, an exemption from any restriction referred
to in paragraph (1) for a period of not longer than 5 years if the person has
established by clear and convincing evidence that the uses to be exempted meet
the exemption criteria described in subparagraph (B).
(B)
Criteria
The
Administrator may grant an exemption for the use of a chemical substance under
subparagraph (A)(ii) if—
(i) the exemption is
in the paramount interest of national security;
(ii) the lack of
availability of the chemical substance would cause significant disruption in
the national economy; or
(iii) the use for
which the exemption is sought is a critical or essential use for which—
(I) no feasible safer
alternative for the specified use of the chemical substance is available;
or
(II) the specified
use of the chemical substance, as compared to all available alternatives,
provides a substantial net benefit to human health, the environment, or public
safety.
(C)
Public
notice
If the Administrator grants an exemption for a chemical
substance under this paragraph—
(i) the manufacturer
or processor of the chemical substance shall provide a notice of the exemption
to each known purchaser of—
(I) the chemical
substance; and
(II) a mixture or
article containing the chemical substance; and
(ii) the
Administrator shall provide the public with a notice of the exemption.
(D)
Renewal
The
Administrator may renew, by order, an exemption under this paragraph for 1 or
more additional 5-year periods if the Administrator concludes, after providing
public notice and an opportunity for comment, that the use of the chemical
substance continues to meet the criteria described in subparagraph (B).
(E)
Conditions
(i)
In
general
The Administrator may impose, by order, any condition on
an exemption issued under this paragraph that the Administrator determines to
be necessary to ensure the protection of human health and the environment on
the use of a chemical substance exempted under this paragraph.
(ii)
Compliance
Effective
immediately after the Administrator establishes conditions on an exempted use
under clause (i), the manufacturing, processing, or distribution in commerce of
the chemical substance, or any mixture or article containing the chemical
substance, shall be prohibited except to the extent that the conditions are
satisfied.
(3)
Sale of used
articles and lease of existing articles
Any restriction referred
to in paragraph (1) that would otherwise be applicable to the sale or lease of
an article shall not apply to—
(A) the sale of an
article that was previously purchased by an end consumer; or
(B) the lease of an
article that was purchased by the lessor subsequent to the manufacture of the
article.
(4)
Extensions of
effective dates for retail sale of articles to end consumers
(A)
In
general
Except as provided in subparagraph (B), in the case of
the retail sale to an end consumer of a chemical substance (or mixture or
article containing that chemical substance) that is subject to a restriction
described in paragraph (1), the Administrator may extend, by order, the
effective date of the restriction by a period of not longer than 3 years, if
the Administrator determines that the extension—
(i) is necessary and
appropriate to allow for depletion of the existing retail inventory; and
(ii) will not present
a substantial endangerment to human health or the environment.
(B)
Exception
An
extension under subparagraph (A) shall not apply to any retailer that the
Administrator determines has failed to comply with an order requesting
information issued by the Administrator pursuant to section
8.
;
(4) in subsection (i)
(as redesignated by paragraph (2))—
(A) by striking
paragraph (4); and
(B) by redesignating
paragraph (5) as paragraph (4); and
(5) by inserting
after subsection (i) (as redesignated by paragraph (2)) the following:
(j)
Mercury
(1)
In
general
Except as provided in paragraph (2), no Federal agency
shall convey, sell, or distribute to any other Federal agency, any State or
local government agency, or any private individual or entity any elemental
mercury, other than mercury contained within an article, under the control or
jurisdiction of the Federal agency.
(2)
Exceptions
Paragraph
(1) shall not apply to—
(A) a transfer
between Federal agencies of elemental mercury for the sole purpose of
facilitating storage of mercury to carry out this Act; or
(B) a conveyance,
sale, distribution, or transfer of coal.
(3)
Leases of
Federal coal
Nothing in this subsection prohibits the leasing of
coal.
(k)
Asbestos
(1)
Exposure
reduction
(A)
Category
Not
later than 90 days after the enactment of the Safe Chemicals Act of 2013, the
Administrator shall designate asbestos as a chemical substance of very high
concern under subsection (b)(3)(B)(i).
(B)
Use and
exposure assessment
Not later than 90 days after the date on
which asbestos is assigned to the category of substances of very high concern
under subsection (b)(3)(B)(i), the Administrator shall complete and publish an
identification and assessment of the known uses of, and exposures to
asbestos.
(C)
Exposure
reduction
As soon as practicable, but not later than 12 months
after the date of enactment of the Safe
Chemicals Act of 2013, the Administrator shall impose, by order,
use restrictions and other conditions, including the conditions specified in
subsection (f) on the manufacturing, processing, use, distribution in commerce,
and disposal of asbestos that the Administrator determines to be necessary to
achieve the maximum practicable reduction in human or environmental exposure to
asbestos. The Administrator shall select conditions that permanently reduce or
eliminate the possibility of exposures to the maximum extent
practicable.
(D)
Timing of
exposure reductions
Except as provided in clauses (i) and (ii) of
subsection (h)(2)(B), effective beginning on the date that is 12 months after
the date of issuance by the Administrator of the order described in
subparagraph (C), no person shall manufacture, process, or distribute in
commerce asbestos subject to the determination, or any mixture or article
containing asbestos, for any use or under any condition other than those
specified in the order issued under subparagraph (C).
(2)
Management of
material
(A)
Draft
guidance
Not later than 180 days after the date of enactment of
the Safe Chemicals Act of 2013,
the Administrator, in consultation with the Director of the National Institutes
of Occupational Safety and Health, shall publish draft guidance describing the
steps that Federal agencies and contractors of Federal agencies shall take to
enhance protections for public health and safety and the environment, and to
better solicit information from members of the public who may potentially be
affected by asbestos, when Federal agencies and contractors of Federal Agencies
handle or dispose of asbestos. The Administrator shall allow 30 days of public
comment on this draft guidance and hold no fewer than two public meetings on
this draft guidance in communities impacted by asbestos contamination.
(B)
Final
guidance
Not later than 12 months after the date of enactment of
the Safe Chemicals Act of 2013,
the Administrator, in consultation with the Director of the National Institutes
of Occupational Safety and Health, shall publish final guidance describing the
steps that Federal agencies and contractors of Federal Agencies shall take to
enhance protections for public health and safety and the environment when
handling and disposing of asbestos. The final guidance shall also include steps
that shall be taken to better solicit information from and protect the health
and safety of people located near areas where asbestos is located, where
asbestos is transported, and where asbestos disposal occurs.
(3)
Definition
For
purposes of this section, the term asbestos has the meaning given
such term under section 202(3).
(4)
No effect on
compliance with environmental laws
Nothing in paragraph (2) or
any amendment made by paragraph (2) shall be construed to affect or limit the
application of or obligation to comply with any environmental law, including
the Comprehensive Environmental Response, Compensation, and Liability Act of
1980 (42 U.S.C. 9601 et seq.).
(l)
Certification
Each
submission required under this section (or a regulation or order promulgated or
issued by the Administrator pursuant to this section) shall be accompanied by a
certification signed by a responsible official of the manufacturer or processor
that each statement contained in the submission—
(1) is accurate and
reliable; and
(2) includes all
material facts required by the applicable provision of this section or rule or
order under this section.
(m)
Effective
date
In any regulation or order under this section, the
Administrator shall specify the date on which the regulation or order shall
take effect, which date shall be as soon as practicable after the date of
promulgation or issuance of the regulation or
order.
.
(b)
Definition of
asbestos
Section 202(3) of the Toxic Substances Control Act (15
U.S.C. 2642(3)) is amended—
(1) in subparagraph
(E), by striking or;
(2) in subparagraph
(F), by striking the period at the end and inserting , and;
and
(3) by adding at the
end the following
(G) any material
formally classified as tremolite, including—
(i) winchire
asbestos, and
(ii) richterite
asbestos, and
(H) any asbestiform
amphibole
mineral.
.
8.
Imminent
hazards
Section 7 of the Toxic
Substances Control Act (15 U.S.C. 2606) is amended to read as follows:
7.
Imminent
hazards
(a)
Actions
authorized and required
(1)
In
general
The Administrator may commence a civil action in an
appropriate district court of the United States for—
(A) seizure of a
chemical substance or mixture, or any article containing a chemical substance
or mixture, that may present an imminent and substantial endangerment to health
or the environment;
(B) relief authorized
under subsection (b) against any person that—
(i) manufactures,
processes, distributes in commerce, uses, or disposes of a chemical substance
or mixture, or any article containing a chemical substance or mixture, if the
manufacture, processing, distribution in commerce, use, or disposal may present
an imminent and substantial endangerment to health or the environment;
or
(ii) contributes to
an activity described in clause (i); or
(C) both seizure and
relief described in subparagraphs (A) and (B), respectively.
(2)
Other
actions
(A)
In
general
The Administrator may issue such orders as are necessary
to protect health or the environment from any manufacturing, processing,
distribution in commerce, use, or disposal of a chemical substance or mixture,
or any article containing such a substance or mixture, that may present an
imminent and substantial endangerment to health or the environment, as
determined by the Administrator.
(B)
Requirement
An
order under subparagraph (A) may include such requirements imposed on the
manufacture, processing, distribution in commerce, use, or disposal of a
chemical substance or mixture, or article containing the chemical substance or
mixture, as the Administrator determines are necessary to protect health or the
environment, including—
(i) the requirements
described in section 6(c); and
(ii) the relief
authorized under subsection (b).
(3)
Relationship to
existing rules, orders, and proceedings
A civil action may be
commenced under paragraph (1), or other action may be taken under paragraph
(2), notwithstanding—
(A) the existence of
a rule or order under this Act; and
(B) the pendency of
any administrative or judicial proceeding under this Act.
(b)
Relief
authorized
(1)
In
general
The district court of the United States in which a civil
action under subsection (a)(1) is brought shall have jurisdiction to grant such
temporary or permanent relief as are necessary to protect health or the
environment from the risk associated with the activity involved in the civil
action.
(2)
Types of
relief
In the case of a civil action under subsection (a)(1)
brought against a person that manufactures, processes, distributes in commerce,
uses, or disposes of a chemical substance or mixture or an article containing a
chemical substance or mixture, the relief authorized by paragraph (1) may
include—
(A) the issuance of a
mandatory order imposing any of the requirements described in section 6(c);
and
(B) in the case of
purchasers of the substance, mixture, or article known to the defendant—
(i) notification to
the purchasers of the risk associated with the substance, mixture, or
article;
(ii) public notice of
the risk;
(iii) recall;
(iv) the replacement
or repurchase of the substance, mixture, or article; or
(v) any combination
of the actions described in section 6(c) or in clauses (i) through (iv) of this
subparagraph; or
(C) such other relief
as is necessary to protect health or the environment from the risk associated
with the activity involved in the civil action.
(3)
Seizure and
condemnation
(A)
In
general
A civil action under subsection (a)(1) against a chemical
substance, mixture, or article may be proceeded against by process of libel for
seizure and condemnation of the chemical substance, mixture, or article.
(B)
Proceedings
Proceedings
in a civil action described in subparagraph (A) shall conform, to the maximum
extent practicable, to proceedings in rem in admiralty.
(c)
Venue and
consolidation
(1)
Venue
(A)
In
general
A civil action under subsection (a)(1) against a person
that manufactures, processes, or distributes a chemical substance or mixture or
an article containing a chemical substance or mixture may be brought in the
United States District Court for the District of Columbia, or in any judicial
district in which any of the defendants is found, resides, or transacts
business.
(B)
Process
Process
in an action described in subparagraph (A) may be served on a defendant in any
other district in which the defendant resides or may be found.
(C)
Chemical
substances, mixtures, or articles
A civil action under subsection
(a)(1) against a chemical substance, mixture, or article may be brought in any
United States district court within the jurisdiction of which the chemical
substance, mixture, or article is found.
(D)
Multiple
judicial districts
In determining the judicial district in which
a civil action may be brought under subsection (a)(1) in instances in which the
action may be brought in more than 1 judicial district, the Administrator shall
take into account the convenience of the parties.
(E)
Subpoenas
Subpoenas
requiring attendance of witnesses in a civil action brought under subsection
(a)(1) may be served in any judicial district.
(2)
Consolidation
If
proceedings under subsection (a)(1) involving identical chemical substances,
mixtures, or articles are pending in courts in 2 or more judicial districts,
the proceedings shall be consolidated for trial by order of any such court on
application reasonably made by any party in interest, on notice to all parties
in
interest.
.
9.
Reporting and
retention of information
Section 8 of the Toxic Substances Control
Act (15 U.S.C. 2607) is amended to read as follows:
8.
Reporting and
retention of information
(a)
Definitions
In
this section:
(1)
Known to, or
reasonably ascertainable by
The term known to, or
reasonably ascertainable by has the meaning given the term in section
704.3 of title 40, Code of Federal Regulations (or successor
regulations).
(2)
Manufacture and
process
The terms manufacture and
process mean manufacture and process, respectively, for commercial
purposes.
(b)
Declarations of
chemical substances in commerce
(1)
Scope and
criteria
(A)
Scope
The
declarations described in this subsection shall apply only to chemical
substances in commerce as of the date of enactment of the
Safe Chemicals Act of
2013.
(B)
Criteria
The
following criteria shall apply in identifying chemical substances to which the
declarations described in this subsection apply:
(i)
Current
commercial interest
A chemical substance in which a manufacturer
or processor has a current commercial interest shall include only chemical
substances that the manufacturer or processor—
(I) is currently
manufacturing or processing; or
(II) has manufactured
or processed in the recent past and expects to manufacture or process again in
the near future.
(ii)
Potential
commercial interest
A chemical substance in which a manufacturer
or processor has a potential commercial interest shall include only a chemical
substance that may serve as a reasonable substitute for a chemical substance in
which the manufacturer or processor has declared a current commercial
interest.
(C)
Guidance
Not
later than 90 days after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall issue guidance further describing the criteria described in
subparagraph (B) and specifying the supporting information manufacturers and
processors are to include in declarations they submit pursuant to paragraph (2)
or (3) for chemical substances in which they have a current or potential
commercial interest.
(2)
Declaration of
current commercial interest in a chemical substance
(A)
In
general
Notwithstanding any other provision of law, not later
than 180 days after the date of enactment of the
Safe Chemicals Act of 2013,
each manufacturer of a chemical substance in which the manufacturer has a
current commercial interest shall submit to the Administrator a declaration of
the interest for the chemical substance.
(B)
Exclusions or
exemptions
Declarations are required for all chemical substances
in which a manufacturer has a current commercial interest, notwithstanding any
exclusions or exemptions from other notification or reporting requirements
provided in any other provision of this Act.
(C)
Processors
A
processor of a chemical substance in which the processor has a current
commercial interest that meets the criteria described in paragraph (1)(B)(i)
may voluntarily submit to the Administrator a declaration for the chemical
substance. Such a declaration shall be submitted not later than 1 year after
the date of enactment of the Safe Chemicals
Act of 2013.
(3)
Declaration of
potential commercial interest in a chemical substance
(A) A manufacturer or
processor may voluntarily submit to the Administrator, not later than 180 days
after the date of enactment of the Safe
Chemicals Act of 2013, a declaration for a chemical substance in
which the manufacturer or processor—
(i) does not have a
current commercial interest; but
(ii) has a potential
commercial interest that meets the criteria described in paragraph
(1)(B)(ii).
(B) If a manufacturer
or processor commences the manufacture or processing of a chemical substance
for which it submitted a declaration under this paragraph, the manufacturer or
processor shall comply with the requirements of subsection (h)(5)(B).
(4)
Declaration of
cessation of manufacturing or processing
A former or current
manufacturer or processor of a chemical substance in which the manufacturer or
processor no longer has a commercial interest may voluntarily submit to the
Administrator, not later than 180 days after the date of enactment of the
Safe Chemicals Act of 2013, a
declaration that the manufacturer or processor has ceased, or will cease not
later than 180 days after the date on which the declaration is submitted, all
production, importation, processing, and export of the chemical
substance.
(5)
Contents
A
declaration submitted under this subsection shall include for each chemical
substance—
(A) the chemical
identity and any special substance characteristics of the chemical
substance;
(B) the identity and
primary business location of the manufacturer or processor; and
(C) information
supporting the declarant’s basis for meeting the applicable criteria under
paragraph (1)(B).
(6)
Review by
Administrator
(A)
In
general
The Administrator shall—
(i) review each
declaration received under this subsection to determine whether the declaration
conforms to the criteria and requirements of this subsection; and
(ii)
(I) for a chemical
substance for which 1 or more conforming declarations are submitted under
paragraph (2), add the chemical substance to the list of active chemical
substances in the inventory established under subsection (h)(1);
(II) for a chemical substance for which the
only conforming declarations submitted for the substance are submitted under
paragraph (3), add the chemical substance to the list of inactive chemical
substances in the inventory established under subsection (h)(5); and
(III) for a chemical substance for which the
only conforming declarations submitted for the substance are submitted under
paragraph (4), or for which no declaration has been submitted, remove the
chemical substance from the inventories established under subsection
(h).
(B)
Revisions
The
Administrator shall allow a manufacturer or processor, as applicable, to
promptly revise and resubmit any declaration submitted to the Administrator
under this subsection if the Administrator determines that any omission or
error in the original declaration was not intentional.
(c)
Periodic
reporting by manufacturers
(1)
In
general
The Administrator shall—
(A) maintain the
periodic reporting program of the agency applicable to manufacturers of
chemical substances set forth in part 711 of title 40, Code of Federal
Regulations (as in effect on the date of enactment of the
Safe Chemicals Act of 2013),
unless such reporting requirements are superseded pursuant to subparagraph (B);
or
(B) establish a new
periodic reporting program consistent with this subsection.
(2)
Rulemaking
(A)
In
general
Not later than 180 days after the date of enactment of
the Safe Chemicals Act of 2013,
the Administrator shall specify, by rule—
(i) the chemical
substances for which periodic reporting is required; and
(ii) the information
a chemical manufacturer is required to submit to the Administrator for the
chemical substances included under the periodic reporting program.
(B)
Exemptions
The
rule promulgated under subparagraph (A) may exempt certain manufacturers,
including small manufacturers, from—
(i) a
requirement to participate in the periodic reporting program, if the
Administrator determines that the participation of those manufacturers would
not assist in the administration of this Act; or
(ii) specific
reporting requirements, if the Administrator determines that the value of a
particular reporting requirement, for the administration of this Act, would not
be commensurate with the burden of the requirement on submitters.
(C)
Contents
The
rule promulgated under subparagraph (A) shall, at a minimum, require each
manufacturer of a chemical substance included in the periodic reporting program
to submit to the Administrator—
(i) the chemical
identity and any special substance characteristics of the chemical substance,
the identity and primary business location of the manufacturer, and any updates
to the supporting information submitted by the manufacturer in any declaration
for an included chemical substance submitted under subsection (b);
(ii) a list of health
and safety studies conducted or initiated by or for, known to, or reasonably
ascertainable by, the manufacturer with respect to each included chemical
substance;
(iii) a copy of each
study described in clause (ii) in the possession or control of the manufacturer
that has not previously been submitted to the Administrator; and
(iv) all other
information specified by the Administrator in the rules promulgated under this
subsection that is known to, in the possession or control of, or reasonably
ascertainable by, the manufacturer or processor that has not previously been
submitted to the Administrator regarding—
(I) the physical,
chemical, and toxicological properties of the chemical substance;
(II) the
manufacturer’s annual production volume of the chemical substance;
(III) the uses of,
and exposure and fate information relating to the manufacturer’s production or
import of the chemical substance; and
(IV) the name and
location of each facility to which the manufacturer sends the chemical
substance after manufacture for subsequent processing, distribution, or
use.
(d)
Records To
support declarations and periodic reports
(1)
In
general
Each manufacturer and processor of a chemical substance
that is distributed in commerce shall—
(A) maintain records
of the information submitted to the Administrator under subsections (b) and
(c), as well as supporting information; and
(B) submit those
records or that information to the Administrator upon request by the
Administrator.
(2)
Burden of
proof
Each manufacturer and processor that submits to the
Administrator a declaration under subsection (b) or a notice under subsection
(h)(5)(B) shall at all times bear the burden of proving that the manufacturer
or processor—
(A) has a current or
potential commercial interest in the applicable chemical substance; or
(B) has ceased the
production, importation, processing, and export of, the applicable chemical
substance.
(e)
Substance
identification and information for chemical processors
(1)
Rulemaking
(A)
In
general
Not later than 1 year after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall specify, by rule, the information that chemical processors
are required to submit for chemical substances under this subsection as will
assist the Administrator in the administration of this Act.
(B)
Exemptions
The
rule promulgated under this paragraph may exempt certain processors, including
small processors, from—
(i) a
requirement to participate in the periodic reporting program, if the
Administrator determines that the participation of those processors would not
assist in the administration of this Act; or
(ii) specific
reporting requirements, if the Administrator determines that the value of a
particular reporting requirement, for the administration of this Act, would not
be commensurate with the burden of the requirement on submitters.
(2)
Information
requirements
The rule promulgated under paragraph (1)
shall—
(A) specify the
information that processors are required to submit for chemical substances that
are—
(i) processed for use
in 1 or more consumer or commercial product categories, as determined by the
Administrator; and
(ii) intentionally
added to 1 or more products during processing and not incidental to the end
uses of the products;
(B) require each
processor of a chemical substance identified under subparagraph (A) to submit
the information specified in clauses (i) through (iii) of subparagraph (C) for
the chemical substance, and to submit the information specified in clauses (iv)
through (viii) of subparagraph (C)—
(i) separately for
each applicable consumer and commercial product category; and
(ii) in aggregate
form, taking into account the use by the processor of the chemical substance in
all product categories;
(C) require each
processor of a chemical substance identified under subparagraph (A) to identify
in the submission of the processor—
(i) the corporate
name and primary business location of the processor;
(ii) the chemical
identity and any special substance characteristics of the chemical
substance;
(iii) the applicable
consumer or commercial product category or categories for which the processor
processes the chemical substance;
(iv) the annual
volume of the chemical substance processed by the submitter;
(v) any products
intended for use by children aged 14 years or younger for use in which the
processor processes the chemical substance;
(vi) the
concentration range within which the maximum concentration of the substance
used in each consumer and commercial product category falls;
(vii) the range
within which the total number of commercial workers reasonably likely to be
exposed to the chemical substance at the processing site falls; and
(viii) any other
information regarding processing activities or product descriptors relating to
the processor’s processing of the chemical substance identified by the
Administrator as necessary to understand the potential exposure from processed
chemical substances or products in which the chemical substances are used;
and
(D) require each
processor to periodically report the information described in subparagraphs (B)
and (C) for the chemical substances described in subparagraph (A).
(3)
Records
The
rules promulgated under paragraph (1) shall require processors of chemical
substances to which those rules apply—
(A) to maintain
records of the information described in paragraph (2); and
(B) to submit those
records to the Administrator upon request by the Administrator.
(f)
Updating of
information
(1)
In
general
Each manufacturer or processor of a chemical substance
that submits information to the Administrator under subsection (c) or (e) shall
update the information—
(A) at a minimum
every 4 years; and
(B) at any time
that—
(i) the manufacturer
or processor obtains knowledge of, comes into possession of, or generates
significant new information regarding the production, processing, use,
distribution, hazard, or exposure potential of the chemical substance;
or
(ii) there is a
significant change in the production, distribution in commerce, or use of the
chemical substance by or known to the manufacturer or processor.
(2)
Guidance
Not
later than 1 year after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall issue guidance on what constitutes significant new
information regarding or significant changes in the production, distribution in
commerce, or use of a chemical substance.
(g)
Reports
(1)
Requirement
(A)
In
general
Except as provided in paragraph (2), the Administrator
may by rule or order require any person who manufactures, processes,
distributes in commerce, uses, or disposes of a chemical substance, or a
mixture or article containing the chemical substance to maintain records of and
report by a specified date any existing information concerning the substance
that, in the judgment of the Administrator, would assist the Administrator
in—
(i) making a safety
standard determination with respect to a chemical substance;
(ii) determining
testing or information needs for a chemical substance;
(iii) assigning a
chemical substance to a batch, category, or priority class pursuant to section
6;
(iv) evaluating,
developing, and implementing risk management conditions for a chemical
substance;
(v) assessing
hazards, exposures, or risks related to the manufacture, use, distribution,
processing, or disposal of a chemical substance;
(vi) determining
compliance with any provision of this Act; or
(vii) any other
aspect of administering this Act.
(B)
Characteristics
The
Administrator may by rule or order require that any report or information
submitted pursuant to this Act include chemical identity and special substance
characteristics, as appropriate to the chemical substance that is the subject
of the report or information.
(C)
Required
information
The Administrator shall by rule or order specify or
modify the information that is required to be submitted with a particular
report or information submission to establish the chemical identity and special
substance characteristics of the subject chemical substance (or mixture or
article containing that chemical substance) for the purposes of the report or
information submission.
(2)
Exemptions
(A)
Small
quantities for research or analysis
In the case of the
manufacture, processing, distribution in commerce, use, or disposal of a
chemical substance in small quantities (as defined by the Administrator by
rule) solely for purposes of scientific experimentation or analysis or chemical
research (including any such research or analysis for the development of a
product), the Administrator may promulgate a rule or order under paragraph (1)
only to the extent that the Administrator determines that the maintenance of
records, submission of reports, or both, is necessary for the effective
enforcement of this Act.
(B)
Small
business
The rules promulgated under this subsection may exempt
certain small businesses from the rules promulgated under this subsection, if
the Administrator determines that the participation of those small businesses
would not assist in the administration of this Act.
(h)
Inventories
(1)
Active
inventory
The Administrator shall compile, keep current, and,
subject to section 14, publish a list of each chemical substance that is
manufactured or processed in the United States.
(2)
Contents
(A)
In
general
The list shall consist of those chemical substances for
which—
(i) a
notice is submitted under section 5(d), consistent with the requirements of
section 5(b); or
(ii) a valid
declaration is submitted under paragraph (2) of subsection (b).
(B)
Exclusions
The
list shall not include—
(i) any chemical
substance for which the only declarations submitted are submitted under
paragraph (3) or (4) of subsection (b), or for which no declaration has been
submitted; or
(ii) any chemical
substance for which an exemption has been granted under section 5(b)(1)(C)(ii)
or section 6(h)(2).
(3)
Timing
(A)
In
general
Except as provided in paragraph (2)(B), for a chemical
substance for which a notice is submitted under section 5(d), the chemical
substance shall be included in the list established under paragraph (1) as of
the earliest date (as determined by the Administrator) on which the substance
was manufactured or processed in the United States.
(B)
Publication
The
Administrator shall first publish a list under paragraph (1) not later than 1
year after the date of enactment of the Safe
Chemicals Act of 2013.
(4)
Small
quantities for research or analysis
The Administrator shall not
include in the list established under paragraph (1) any chemical substance that
is manufactured or processed only in small quantities (as defined by the
Administrator by rule) solely for purposes of scientific experimentation or
analysis or chemical research on, or analysis of, the substance or another
substance, including research or analysis for the development of a
product.
(5)
Inactive
inventory
(A)
In
general
The Administrator shall compile, keep current, and,
subject to section 14, publish an inactive list on which the Administrator
shall include each chemical substance for which the only declarations submitted
for the substance are submitted under subsection (b)(3).
(B)
Requirements
If
a manufacturer or processor commences the manufacture or processing of a
chemical substance on the inactive list, the manufacturer or processor
shall—
(i) not less than 30
days before recommencing the manufacture or processing of the chemical
substance, notify the Administrator; and
(ii) provide with the
notification under clause (i)—
(I) the chemical
identity and any special substance characteristics of the chemical
substance;
(II) the identity and
primary business location of the manufacturer;
(III) a list of
health and safety studies conducted or initiated by or for, known to, or
reasonably ascertainable by, the manufacturer or processor with respect to the
chemical substance;
(IV) upon request of
the Administrator, a copy of each study described in subclause (III) in the
possession or control of the manufacturer that has not previously been
submitted to the Administrator;
(V) the projected
annual manufacturing or processing volume for the chemical substance for each
of the subsequent 3 years;
(VI) the name and
location of each facility to which the chemical substance is expected to be
sent, after manufacture or processing, for subsequent processing, distribution
in commerce, or use; and
(VII) all other
existing information known to, in the possession or control of, or reasonably
ascertainable by the manufacturer or processor that has not previously been
submitted to the Administrator regarding—
(aa) the
toxicological properties of the chemical substance; and
(bb) the uses of, and
exposure and fate information relating to, the chemical substance.
(C)
Administrator
actions
For any chemical substance for which the Administrator
receives a valid notification under subparagraph (B), the Administrator shall
promptly—
(i) move the chemical
substance to the active inventory established under paragraph (1); and
(ii) add the chemical
substance to the current batch of chemical substances identified pursuant to
section 6(a), and categorize the chemical substance with other chemical
substances in the batch, pursuant to section 6(b).
(D)
Administration
Disclosure
of any information provided in the notice described in subparagraph (B) shall
be subject to section 14.
(6)
Chemicals not
listed on or removed from the inventories
If a manufacturer or
processor seeks to commence the manufacture or processing of a chemical
substance that is not listed on the inventories established under paragraph (1)
or (5), or that has been removed from the inventories pursuant to subsection
(b)(6)(A)(ii)(III), the manufacturer or processor shall comply with section
5.
(i)
Public access
to significant information
(1)
Electronic
database
Not later than 1 year after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator, through collaboration as appropriate, shall establish—
(A) an electronic,
Internet-accessible database for the storing and sharing of information
relating to the toxicity and use of, and exposure to, chemical substances;
and
(B) procedures for
use in maintaining and updating the database.
(2)
Public
access
Not later than 18 months after the date of enactment of
the Safe Chemicals Act of 2013
or for decisions made or information submitted after that 18-month period, not
later than 90 days after the date on which a decision is made by the
Administrator or information submitted under this title is received by the
Administrator, the Administrator shall, subject to section 14, make available
to the public via the Internet-accessible database described in paragraph (1) a
description of all significant—
(A) decisions made by
the Administrator under this title; and
(B) information
submitted pursuant to this title.
(j)
Records of
significant adverse reactions
(1)
In
general
Any person that manufactures, processes, or distributes
in commerce any chemical substance shall maintain, and on request submit to the
Administrator, records of significant adverse reactions to human health or the
environment, as determined by the Administrator by rule, alleged to have been
caused by the substance or mixture.
(2)
Duration
(A)
In
general
Records of the adverse reactions to the health of
employees shall be retained for a period of 30 years after the date on which
the reactions were first reported to or known by the person maintaining the
records.
(B)
Other
records
Any record of other adverse reactions shall be retained
for a period of 5 years after the date on which information contained in the
record was first reported to or known by the person maintaining the
record.
(3)
Contents
Records
required to be maintained under this subsection shall include—
(A) records of
consumer allegations of personal injury or harm to health;
(B) reports of
occupational disease or injury; and
(C) reports or
complaints of injury to the environment submitted to the manufacturer,
processor, or distributor in commerce from any source.
(k)
Information in
the possession of other federal agencies
(1)
Synopses
(A)
In
general
Notwithstanding any other provision of law, from time to
time, each Federal agency and Federal institution shall submit to the
Administrator a synopsis of the data and records in the possession or control
of the agency or institution, respectively, that may be useful to the
Administrator in carrying out this Act.
(B)
Format and
content
Not later than 1 year after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall prescribe, by order, the format, content, and level of
detail of the synopses.
(C)
Initial
submission
Not later than 18 months after the date of enactment
of the Safe Chemicals Act of
2013, each Federal agency and Federal institution shall make the
initial submission of a synopsis of the agency and institution, respectively,
to the Administrator.
(D)
Updates
At
least once every 3 years, each Federal agency and Federal institution
shall—
(i) update the
synopsis of the agency and institution, respectively; and
(ii) submit the
updated synopsis to the Administrator.
(2)
Requests by the
administrator
Notwithstanding any other provision of law, on the
request of the Administrator, any information in the possession or control of
an agency or institution relating to a hazard of, use of, exposure to, or risk
of, a chemical substance (or mixture or article containing that chemical
substance) shall be submitted to the Administrator.
(l)
Notice to
administrator of substantial risks
Any person that manufactures,
processes, or distributes in commerce a chemical substance and that obtains
information that reasonably supports the conclusion that the substance presents
a substantial risk of injury to health or the environment shall immediately
inform the Administrator of the information unless the person has actual
knowledge that the Administrator has been adequately informed of the
information.
(m)
Certification
Each
submission required pursuant to this section or pursuant to a rule or an order
promulgated or issued by the Administrator under this section, other than a
submission under subsection (k), shall be accompanied by a certification signed
by a responsible official of the manufacturer, processor, distributor, user, or
disposer of a chemical substance that each statement contained in the
submission—
(1) is accurate and
reliable; and
(2) includes all
material facts required by the applicable provision of this section or rule or
order under this section.
(n)
Administration
(1)
In
general
Nothing in this section limits the authority of the
Administrator to require reporting under any other provision of this Act by any
person who manufactures, processes, distributes in commerce, uses, or disposes
of a chemical substance, or a mixture or article containing a chemical
substance.
(2)
Violations
In
addition to all other authorities available for the enforcement of this Act,
the Administrator may, by order, take any action authorized under section 6(f)
if a person who manufactures, processes, distributes in commerce, uses, or
disposes of a chemical substance, or a mixture or article containing a chemical
substance violates any provision of this
section.
.
10.
Relationship to
other Federal laws
Section 9
of the Toxic Substances Control Act (15 U.S.C. 2608) is amended—
(1) in subsection
(a)—
(A) by striking
paragraphs (1) and (2) and inserting the following:
(1)
Report
(A)
In
general
If the Administrator determines that the manufacture,
processing, distribution in commerce, use, or disposal of a chemical substance,
or that any combination of those activities, does not meet a safety standard
under this title or requires conditions or restrictions in order to the meet
the safety standard, and the Administrator determines that action may be taken
under a Federal law not administered by the Administrator to address the uses
of, or exposure to, the chemical substance, the Administrator shall submit to
the agency that administers the Federal law a report that—
(i) describes with
specification the activity or combination of activities that prevent the
chemical substance from meeting the safety standard or restrictions or
conditions required to meet the safety standard under this title;
(ii) requests that
the agency—
(I) determine whether
the 1 or more actions may be taken under Federal law administered by the
agency;
(II) if the agency
determines under clause (i) that the 1 or more actions may be taken, initiate
and provide a timetable for the 1 or more actions; and
(III) respond to the
Administrator with respect to the matters described in the report; and
(iii) includes a
detailed statement of the information on which the report is based.
(B)
Publication
A
report of the Administrator submitted under subparagraph (A) shall be promptly
published in the Federal Register.
(C)
Action by
recipient agency
Not later than 90 days after the date of receipt
of a report from the Administrator under subparagraph (A), or by such earlier
date as the Administrator may specify in such a report, an agency that receives
the report shall—
(i) make all
determinations requested by the Administrator in the report;
(ii) take all action
necessary to ensure that a chemical substance meets the safety standard under
this title, if appropriate;
(iii) include with
the response of the agency a detailed statement of the findings and conclusions
of the agency; and
(iv) publish that
statement in the Federal Register.
(2)
Initiation of
action
If the Administrator submits a report under paragraph (1)
with respect to a chemical substance to an agency, and the agency that receives
the report initiates, within the period specified in the request under
paragraph (1), a civil action under Federal law administered by the agency to
ensure that a chemical substance meets the safety standard under this title, or
requires restrictions or conditions to meet that safety standard, the
Administrator may not take action under this Act with respect to the civil
action (other than any action taken pursuant to section
7).
;
(B) by redesignating
paragraph (3) as paragraph (4);
(C) by inserting
after paragraph (2) the following:
(3)
No
action
The Administrator may, by order, initiate action or a
combination of actions under this Act to ensure compliance with the safety
standard for a chemical substance under this title if—
(A) the Administrator
submits a report under paragraph (1) with respect to a chemical substance;
and
(B) the agency to
which the report was submitted—
(i) determines that
action cannot be taken under the authorities of the agency;
(ii) does not
initiate action, if appropriate, within the period specified in the request
under paragraph (1);
(iii) does not
complete the action within the timeframe provided by the agency; or
(iv) fails to
respond.
;
and
(D) in paragraph (4)
(as redesignated by subparagraph (B))—
(i) by
striking (4) If the Administrator has initiated action under section 6
or 7 and inserting the following:
(4)
Consultation
If
the Administrator has initiated action under this
Act
;
and
(ii) by
striking against such risk after Federal
action;
(2) in subsection
(c)—
(A) by striking
the Administrator shall not and
inserting
Administrator—
(1) shall
not
;
and
(B) by striking the
period at the end and inserting ; and; and
(C) by adding at the
end the following:
(2) shall ensure that
any actions to address workplace exposures that the Administrator takes or
requires to be taken by manufacturers or processors of a chemical substance are
consistent with the industrial hygiene hierarchy of
controls.
;
and
(3) in subsection
(d)—
(A) in the first
sentence, by striking while imposing the least burden of duplicative
requirements on those subject to the Act and for other purposes;
and
(B) in the second
sentence, by striking , in the report required by section
30,.
11.
Inspections and
subpoenas
Section 11 of the
Toxic Substances Control Act (15 U.S.C. 2610) is amended to read as
follows:
11.
Inspections and subpoenas
(a)
Inspections
(1)
In general
For purposes of
administering this Act, the Administrator, and any duly designated
representative of the Administrator, may inspect—
(A) any
establishment, facility, or other premises in which chemical substances,
mixtures, or articles subject to this Act are manufactured, processed, stored,
or held before or after distribution in commerce;
(B) any conveyance
being used to transport such chemical substances, mixtures, or articles in
connection with distribution in commerce; and
(C) any place at
which records relating to the chemical substances, mixtures, or articles, or
otherwise relating to compliance with this Act, are held.
(2)
Method
Each
inspection under paragraph (1) shall be—
(A) commenced and
completed with reasonable promptness; and
(B) conducted at
reasonable times, within reasonable limits, and in a reasonable manner.
(3)
Samples
The
Administrator, and any duly designated representative of the Administrator, may
inspect and obtain samples of any—
(A) chemical
substance, mixture, or article; and
(B) container or
labeling of a chemical substance, mixture, or article.
(b)
Scope
An
inspection conducted under subsection (a) shall extend to all things within the
premises or conveyance inspected (including records, files, papers, processes,
controls, and facilities) regarding whether the owner or operator of the
premises, conveyance, or records has complied with provisions of this Act
applicable to the chemical substances, mixtures, articles, or records.
(c)
Information
gathering
(1)
In
general
In carrying out this Act, the Administrator may require
the attendance and testimony of witnesses and the production of such reports,
papers, documents, items, answers to questions, and other information,
including the development of analyses and other information, as the
Administrator determines to be necessary.
(2)
Payment of
witnesses
A witness described in paragraph (1) shall be paid the
same fees and mileage that are paid witnesses in the courts of the United
States.
(d)
Warrants
For
purposes of enforcing this Act, upon a showing to an officer or court of
competent jurisdiction that there is reason to believe that a provision of this
Act has been violated, officers or employees duly designated by the
Administrator are empowered to obtain and to execute warrants
authorizing—
(1) entry,
inspection, and copying of records for purposes of this Act; and
(2) the seizure of
any chemical substance, mixture, or article that is in violation of this
Act.
.
12.
Exports
Section 12 of the Toxic Substances Control
Act (15 U.S.C. 2611) is amended—
(1) by striking
subsection (a);
(2) by redesignating
subsections (b) and (c) as subsections (a) and (b), respectively;
(3) in subsection (a)
(as redesignated by paragraph (2))—
(A) in paragraph
(1)—
(i) by
striking or intends to export;
(ii) by
striking section 4 or 5(b) and inserting section 4, 5, or
6(b);
(iii) by striking
or intent to export and inserting , not later than 30
days after the date of exportation of the substance or mixture,;
and
(iv) by
inserting promptly thereafter before
furnish;
(B) in paragraph
(2)—
(i) by
striking or intends to export;
(ii) by
striking an order has been issued under section 5 or a rule has been
proposed or promulgated under section 5 or 6, or with respect to which an
action is pending or relief has been granted under section 5 or 7 and
inserting an action has been taken pursuant to section 6 or
7;
(iii) by striking
or intent to export and inserting , not later than 30
days after the date of exportation of the substance or mixture,;
(iv) by
inserting promptly thereafter before furnish;
and
(v) by
striking such rule, order, action, or relief and inserting
the action taken pursuant to section 6 or 7; and
(C) by adding at the
end the following:
(3)
Change in
export status
(A)
In
general
Any person that has notified the Administrator of the
exportation of a chemical substance or mixture under this section shall notify
the Administrator of any change in the export status of the substance or
mixture by not later than 30 days after such a change in status.
(B)
Updated
notice
The Administrator shall promptly furnish an updated notice
to the governments that have been notified pursuant to paragraphs (1) and (2)
regarding the exportation of any chemical substance or mixture subject to this
section if—
(i) data for the
substance or mixture have been received by the Administrator pursuant to
section 4, 5, 6(b), or 8;
(ii) a change has
occurred in the export status of the substance or mixture; or
(iii) a change has
been made in any risk management action taken pursuant to section 6 or 7 for
the substance or
mixture.
;
(4) in subsection
(b), as redesignated by paragraph (2) of this section—
(A) by striking
paragraph (2); and
(B) by redesignating
paragraphs (3), (4), (5), and (6) as paragraphs (2), (3), (4), and (5),
respectively; and
(5) by adding at the
end the following:
(c)
Public
records
The Administrator shall—
(1) maintain copies
of all current notices provided to other governments under this section;
and
(2) make such copies
available to the public in electronic
format.
.
13.
Entry into
customs territory of the United States
Section 13 of the Toxic Substances Control
Act (15 U.S.C. 2612) is amended—
(1) by striking
Secretary of the Treasury each place it appears and inserting
Secretary of Homeland Security;
(2) in subsection
(a)—
(A) in paragraph (1),
by striking if— and subparagraphs (A) and (B) and inserting
if the substance, mixture, or article fails to comply with or is offered
for entry in violation of any rule or order in effect under this Act.;
and
(B) by adding at the
end the following:
(3)
Import as part
of an article
Chemical substances and mixtures imported as part
of an article shall be subject to the same requirements under this Act as if
the substances and mixtures had been imported in bulk, except as the
Administrator may provide by rule under this Act, or as the Secretary of
Homeland Security may provide by rule under subsection
(b).
.
14.
Disclosure of
data
Section 14 of the Toxic
Substances Control Act (15 U.S.C. 2613) is amended to read as follows:
14.
Disclosure of
data
(a)
Applicability
(1)
In
general
Subject to paragraph (2) and except as provided under
subsections (b) and (e), any information reported to, or otherwise obtained by,
the Administrator (or any representative of the Administrator) that is exempt
from disclosure under subsection (a) of section 552 of title 5, United States
Code, (commonly known as the Freedom of Information Act) under
subsection (b)(4) of that section, shall not be disclosed by the Administrator
or by any officer or employee of the United States, unless the designation of
the information as exempt from disclosure is prohibited under Federal
law.
(2)
Exemptions
(A)
Mandatory
exemptions
Notwithstanding any other provision of law, the
Administrator shall disclose the information described in paragraph (1)—
(i) to any officer or
employee of the United States—
(I) in connection
with the official duties of that officer or employee under any law for the
protection of human health or the environment; or
(II) for specific law
enforcement purposes;
(ii) to a contractor
with the United States and employees of that contractor if, in the opinion of
the Administrator, the disclosure is necessary for the satisfactory performance
by the contractor of a contract with the United States entered into on or after
the date of enactment of the Safe Chemicals
Act of 2013 for the performance of work in connection with this
Act and under such conditions as the Administrator may specify;
(iii) if the
Administrator determines that the disclosure is necessary to protect human
health or the environment;
(iv) on request, to a
State or tribal government for the purpose of development or potential
development, administration, or enforcement of a law, if 1 or more applicable
agreements ensure that the recipient government will take appropriate steps,
and has adequate authority, to maintain the confidentiality of the information
in accordance with procedures comparable to those which the Administrator uses
to safeguard the information; and
(v) on request, to
public health or environmental health professionals or medical personnel if the
Administrator determines that—
(I) disclosure is in
the public interest;
(II) the recipient
does not have a conflict of interest or competitive interest with respect to
the submitter of the information; and
(III) 1 or more
applicable agreements are in place to ensure that the recipient of the
information provides comparable protections to those provided by the
Administrator to maintain the confidentiality of the information.
(B)
Optional
exemptions
Notwithstanding any other provision of law, the
Administrator may disclose the information described in paragraph (1) if
relevant, in any proceeding under this Act, except that disclosure in such a
proceeding shall be made in such manner as to preserve confidentiality to the
maximum extent practicable without impairing the proceeding.
(3)
Effect on other
laws
In any proceeding under section 552(a) of title 5, United
States Code (commonly referred to as the Freedom of Information
Act), to obtain information, the disclosure of which has been denied
pursuant to this section, the Administrator may not rely on subsection (b)(3)
of that section to sustain the action of the Administrator.
(b)
Categories of
confidential business information
(1)
Information
that is always eligible for protection
Subject to subsection
(a)(2) and any other applicable provision of Federal law, the Administrator
shall review and approve a request that conforms to the requirements described
in subsection (c)(2) to treat as confidential under this section the following
information:
(A) Precise
information describing the manufacture, processing, or distribution of a
chemical substance or mixture.
(B) Marketing and
sales information.
(C) Information
identifying the customers of a manufacturer, processor, or distributor.
(D) Details of the
full composition of a mixture of a particular manufacturer or processor.
(E) Precise
information about the use, function, or application of a chemical substance or
mixture in a process, mixture, or product of a particular manufacturer or
processor.
(F) Precise
production or import volumes of a particular manufacturer, processor, or
distributor.
(2)
Information
that may be eligible for protection
(A)
In
general
Subject to subsection (a) and any other applicable
provision of Federal law, and except as provided in paragraphs (1) and (3),
information submitted by a manufacturer, processor, or distributor to the
Administrator may be protected if the manufacturer, processor, or distributor
complies with subsection (c)(2) and the Administrator determines that a request
to maintain the confidentiality of the information meets the applicable
requirements of this subsection and any rule promulgated by the Administrator
under subsection (c)(1).
(B)
Identities of
certain chemical substances
(i)
In
general
Notwithstanding subparagraph (A), the Administrator shall
not disclose precise information on the identity of a chemical substance
if—
(I) the manufacturer
or processor of the substance has, in accordance with subsection (c)(2)—
(aa) included in a
notice under section 5(b) a request, including a justification and
documentation for the request, that the identity of the substance be treated as
confidential business information; or
(bb) submitted to the
Administrator not later than 180 days after the date of enactment of the
Safe Chemicals Act of 2013 a
request, including a justification and documentation for the request, that the
identity of a substance for which a notice has been submitted under section
5(b) as of the date of enactment of the Safe
Chemicals Act of 2013 be treated as confidential business
information; and
(II) the
Administrator determines that—
(aa) the request
complies with all applicable requirements of this section;
(bb) the chemical
identity is not readily discoverable through reverse engineering;
(cc) the manufacturer
or processor takes reasonable measures to protect the confidentiality of the
chemical substance;
(dd) no
other Federal statute requires disclosure;
(ee) disclosure of
the identity of the chemical substance would cause financial or competitive
harm to the manufacturer or processor;
(ff) the chemical
substance is not, based on information that is initially available or that
later becomes available to the Administrator, a known or probable reproductive,
developmental, neurological, or immunological toxicant, carcinogen, or
mutagen;
(gg) the chemical
substance is not persistent, bioaccumulative, and toxic; and
(hh) if
a safety standard determination has been made for a chemical substance, the
Administrator determines that the chemical substance meets the applicable
safety standard either under current conditions or under additional conditions
required by the Administrator.
(ii)
Notice
In
cases where all of the requirements specified in clause (i) are met—
(I) the notice
required to be made public by the Administrator under section 5(f)(3) shall
include a justification for the determination of the Administrator and identify
the chemical substance by generic class unless the Administrator determines
that more specific identification is required in the public interest;
and
(II) as part of a
claim to protect the identity of a chemical substance under subsection (c)(2),
a manufacturer or processor may provide a public name for the
chemical substance for use by the Administrator when sharing information on the
chemical substance under this subsection. The public names should disclose a
maximum amount of information on the chemical structure of the substance, while
protecting those features of the chemical structure that are considered
confidential and the disclosure of which would potentially harm the owner of
that information.
(iii)
Duration of
protection for chemical identity
Notwithstanding subsection
(c)(1)(B)(iv), the identity of a chemical substance for which a request has
been submitted pursuant to clause (i)(I) and meets the requirements of clause
(i) shall be protected as confidential business information—
(I) for such period
of time as the Administrator, after reviewing the request, determines to be
reasonable; and
(II) upon expiration
of a time period specified under this clause, for an additional 5-year period,
if the Administrator, after reviewing the request, determines that the request
for protection continues to meet the criteria established in this
subparagraph.
(iv)
Publication
requirement
The Administrator shall annually publish a notice
that—
(I) includes an
updated, cumulative list of each new chemical substance for which the
Administrator has approved a request to protect information under this
paragraph, identified by a unique identifier, other than the precise chemical
identity, and including the period of time for which the protection applies;
and
(II) for each
chemical substance for which the protection provided under this paragraph has
expired, provides the precise identity of the chemical substance, and provides
public access to any information that had been submitted to the Administrator
which concealed the identity of the chemical substance in accordance with this
paragraph.
(C)
Impurities
Notwithstanding
subparagraph (A), the Administrator may determine not to disclose information
relating to the degree of purity or the identity of impurities present in a
chemical substance or mixture if the Administrator determines that knowledge of
the information would reveal processes used in the manufacturing or processing
of the chemical substance or mixture.
(3)
Information
that is never eligible for protection
(A)
In
general
Except as provided in paragraph (2), the Administrator
shall disclose the following information:
(i) The identity of a
chemical substance.
(ii) Any safety
standard determination developed under section 6, including supporting analysis
developed by the Administrator.
(iii) Any health and
safety study data that is submitted under this Act with respect to—
(I) any chemical
substance or mixture—
(aa) that has been
offered for commercial distribution as of the date on which the study is to be
disclosed; or
(bb) for which
testing is required under section 4 or for which notification is required under
section 5; and
(II) any data
reported to, or otherwise obtained by, the Administrator from a health and
safety study that relates to a chemical substance or mixture described in
subclause (I).
(iv) Health and
safety data in notices of substantial risk submitted pursuant to section 8(l)
and in the underlying studies.
(v) General
information describing the manufacturing volumes, expressed in ranges, and
industrial, commercial, or consumer functions and uses of a chemical substance
or mixture.
(vi) Any information
indicating the presence of a chemical substance in consumer products intended
for use, or reasonably expected to be used, by children aged 14 years or
younger, if—
(I) the
Administrator, or another authoritative body, has determined that the chemical
substance—
(aa) is
a known or probable reproductive, developmental, neurological, or immunological
toxicant, carcinogen, or mutagen; or
(bb) is
persistent, bioaccumulative, and toxic; or
(II) for a chemical
substance for which a safety standard determination has been made, the
Administrator has not found that the chemical substance meets the safety
standard.
(B)
Prohibition
Nothing
in this paragraph authorizes the release of any data that discloses a process
used in the manufacturing or processing of a chemical substance or mixture, or
in the case of a mixture, the release of data disclosing the portion of the
mixture comprised by any of the chemical substances in the mixture.
(C)
Applicability
of other laws
Except as provided in paragraph (2), if the
Administrator receives a request for information under section 552(a) of title
5, United States Code, (commonly known as the Freedom of Information
Act) for information described in subparagraph (A), which is not
information described in subparagraph (B), the Administrator shall not deny the
request under subsection (b)(4) of that section.
(c)
Designation and
treatment of confidential business information
(1)
Duties of the
administrator
(A)
Rules
Not
later than 1 year after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall promulgate rules that specify—
(i) the acceptable
bases on which written requests to maintain confidentiality of information may
be approved, which shall be consistent with the requirements of this
section;
(ii) the nature of
the documentation and justification that must accompany such a request;
and
(iii) the types of
information the Administrator determines warrant protection for an indefinite
period of time, for which the term of confidentiality specified in subparagraph
(B)(iv)(I) shall not apply.
(B)
Review of
requests
(i)
In
general
Not later than 90 days after the date of receipt of
information under paragraph (2), the Administrator shall review a request to
maintain confidentiality of information submitted under this Act and determine
whether to approve, modify, or deny that request based on the regulations
promulgated by the Administrator under subparagraph (A).
(ii)
Process
The
Administrator shall, in accordance with clause (i)—
(I) review all
requests received to maintain confidentiality of submitted information;
or
(II) if it is not
feasible for the Administrator to review all of the requests—
(aa) review all
requests relating to information described in subsection (b)(2)(B); and
(bb) review a
representative subset that includes not less than 25 percent of all other
requests received; and
(III) publish in the
Federal Register on at least an annual basis a description of the number and
types of requests received and reviewed by the Administrator.
(iii)
Denials
If
a request to maintain confidentiality of submitted information is denied in
accordance with subparagraph (D), the Administrator shall promptly make the
information available to the public in accordance with section 8(i)(2).
(iv)
Approvals
If
a request to maintain confidentiality of submitted information is approved, the
Administrator shall—
(I) except with
respect to requests subject to a rule issued pursuant to subparagraph (A)(iii)
and requests submitted pursuant to subsection (b)(2)(B)(i)(I), specify a time
period not to exceed 5 years for which the submitted information shall be kept
confidential, unless the information otherwise becomes available to the public
during the period; and
(II) upon the
expiration of the protection period, make the information available to the
public unless the manufacturer, processor, or distributor has submitted,
documented, and justified to the satisfaction of the Administrator and in
accordance with this subsection the basis for a renewal of the protection, for
a time period not to exceed 5 years.
(C)
Authority of
the administrator
Nothing in subparagraph (A) or (B) limits the
authority of the Administrator to determine that particular information,
previously treated as confidential, is no longer entitled to confidential
treatment.
(D)
Notifications
(i)
In
general
Except as provided in clause (ii), if the Administrator
proposes to release information for which a request for confidential treatment
has been approved under this section, the Administrator shall electronically
notify the manufacturer, processor, or distributor in commerce who submitted
the request of the intent of the Administrator to release the information not
less than 15 days prior to the release of the information.
(ii)
Administration
The
Administrator shall release the information described in clause (i) in
accordance with the disclosure and procedural requirements of section 552 of
title 5, United States Code (commonly known as the ‘Freedom of Information
Act’), except that—
(I) if the release of
the information is to be made pursuant to a request made under section 552(a)
of title 5, United States Code, the notice shall be given immediately upon
approval of the request by the Administrator;
(II) if the
Administrator determines that the release of information pursuant to subsection
(a)(2)(A)(iii) is necessary to protect against imminent and substantial harm to
human health or the environment, no notice shall be required; and
(III) the
requirements of this subparagraph shall not apply to the release of information
under—
(aa) clauses (i)
through (iii) of subsection (a)(2)(A); or
(bb) subsection
(b)(3)(A).
(2)
Duties of
manufacturers, processors, and distributors
(A)
In
general
In submitting data under this Act, a manufacturer,
processor, or distributor in commerce may—
(i) designate
information, other than information described in subsection (b)(3), for which
the manufacturer, processor, or distributor requests confidential treatment
under subsection (a) or (b); and
(ii) submit the
designated data separately from other data submitted under this Act.
(B)
Requirements
A
designation under this paragraph shall be made in writing and in such manner as
the Administrator may prescribe, and shall include—
(i) documentation and
justification for each request for confidentiality, except for requests
relating to the information described in subsection (b)(1);
(ii) the period of
time for which maintenance of confidentiality of the information is requested
except with respect to requests subject to a rule issued pursuant to subsection
(c)(1)(A)(iii);
(iii) a certification
that the information is not otherwise publicly available;
(iv) separate copies
of all submitted information, with 1 copy containing and 1 copy excluding the
information to which the request applies; and
(v) any additional
information required by the Administrator.
(C)
Request for
renewal
Prior to the expiration of the specified time period
determined by the Administrator under paragraph (1)(B)(iv), a manufacturer,
processor, or distributor may submit a request for renewal of protection for
protected information. This request for renewal shall follow the same
procedures and requirements as the initial submission under subparagraphs (A)
and (B).
(d)
Civil penalty
for wrongful disclosure or wrongful requests for protection
(1)
In
general
Any officer or employee of the United States or former
officer or employee of the United States, who, by virtue of employment or
official position has obtained possession of, or has access to, material the
disclosure of which is prohibited by subsection (a), and who knowing that
disclosure of the material is prohibited by that subsection, willfully
discloses the material in any manner to any person not entitled to receive the
information, shall be subject to appropriate disciplinary action and subject to
a civil money penalty of not more than $10,000 for each violation.
(2)
Applicability
of other laws
Section 1905 of title 18, United States Code, shall
not apply with respect to the publishing, divulging, disclosure, making known,
or making available of, information reported or otherwise obtained under this
Act.
(3)
Contractors
For
the purposes of paragraph (1), any contractor with the United States who is
furnished information as authorized by subsection (a)(2), including any
employee of such a contractor, shall be considered to be an employee of the
United States.
(4)
False
requests
Any officer or employee of a company that submits
information under this Act who willfully designates information as eligible for
confidential treatment, knowing that the information is ineligible for such
treatment, shall be subject to a civil money penalty of not more than $10,000
for each such violation.
(e)
Access by
congress
Notwithstanding this section or any other provision of
law, all information reported to or otherwise obtained by the Administrator (or
any representative of the Administrator) under this Act shall be made
available, on written request of any duly authorized committee of Congress, to
that committee.
(f)
Risk
information for workers
The Administrator shall facilitate the
sharing of information that pertains to chemical substances or mixtures or
articles containing chemical substances that workers may come into contact with
or may otherwise be exposed to during the course of work with those workers and
representatives of each certified or recognized bargaining agent representing
those workers. Nothing in this subsection authorizes disclosure of information
other than those disclosures that may be made pursuant to subsections (a)
through
(e).
.
15.
Prohibited
acts
Section 15 of the Toxic
Substances Control Act (15 U.S.C. 2614) is amended—
(1) by striking
paragraph (1) and inserting the following:
(1) fail or refuse to
comply with any rule, order, prohibition, restriction, or other requirement
imposed by this Act or by the Administrator under this
Act;
;
(2) in paragraph
(2)—
(A) by striking
use and inserting manufacture, process, distribute in
commerce, use, or dispose of;
(B) by striking
or mixture and inserting , mixture, or article;
and
(C) by striking
section 5 or 6, a rule or order under section 5 or 6, or an order issued
in action brought under section 5 or 7 and inserting any rule,
order, prohibition, restriction, or other requirement imposed by this Act or by
the Administrator under this Act;
(3) in paragraph
(3)—
(A) in subparagraph
(A), by inserting accurate and complete after
maintain;
(B) in subparagraph
(B)—
(i) by
inserting or make accurate and complete after
submit; and
(ii) by
inserting information submissions, disclosures, declarations,
certifications, after notices,; and
(C) in subparagraph
(C), by striking or after the semicolon;
(4) in paragraph (4),
by striking the period at the end and inserting a semicolon; and
(5) by adding at the
end the following:
(5) make or submit a
statement, declaration, disclosure, certification, writing, data set, or
representation that is materially false, in whole or in part, or to falsify or
conceal any material fact, in taking any action or making any communication
pursuant to this Act or pursuant to any rule or order promulgated or issued
under this Act; or
(6) take any action
prohibited by this
Act.
.
16.
Penalties
Section 16 of the Toxic Substances Control
Act (15 U.S.C. 2615) is amended—
(1) in subsection
(a)—
(A) in paragraph
(1)—
(i) in
the first sentence—
(I) by inserting
this Act or a rule or order promulgated or issued pursuant to this Act,
as described in after a provision of; and
(II) by striking
$25,000 and inserting $37,500; and
(ii) in
the second sentence, by striking violation of section 15 or 409
and inserting violation of this Act;
(B) by redesignating
paragraphs (2), (3), and (4) as paragraphs (3), (4), and (5),
respectively;
(C) by inserting
after paragraph (1) the following:
(2) In the case of
any violation described in paragraph (1), the Administrator may commence a
civil action in the appropriate United States district court to assess
penalties pursuant to that
paragraph.
;
(D) in subparagraph
(A) of paragraph (3) (as redesignated by subparagraph (B))—
(i) in
the first sentence, by inserting this Act, as described in
before section 15 or 409; and
(ii) in
the last sentence, by striking within 15 days of and inserting
not later than 15 days after;
(E) in the first
sentence of paragraph (4) (as redesignated by subparagraph (B))—
(i) by
striking paragraph (2)(A) and inserting paragraph
(3)(A); and
(ii) by
striking the United States Court of Appeals for the District of Columbia
Circuit or for any other circuit and inserting the appropriate
district court of the United States for the district; and
(F) in paragraph (5)
(as redesignated by subparagraph (B)), by striking paragraph (3)
each place it appears and inserting paragraph (4); and
(2) in subsection
(b)—
(A) by striking
Any person and inserting the following:
(1)
In
general
Any
person
;
(B) by striking
or willfully;
(C) by inserting
this Act, as described in after any provision
of;
(D) by striking
$25,000 and inserting $50,000;
(E) by striking
one year and inserting 5 years; and
(F) by adding at the
end the following:
(2)
Imminent danger
of death or serious bodily injury
(A)
In
general
Any individual who knowingly violates any provision of
this Act and who knows at the time that the violation places another person in
imminent danger of death or serious bodily injury shall upon conviction be
subject to a fine of not more than $250,000, or imprisonment of not more than
15 years, or both.
(B)
Other
persons
A person that is not an individual shall, upon conviction
of violating this paragraph, be subject to a fine of not more than
$1,000,000.
.
17.
Specific
enforcement and seizure
Section 17 of the Toxic Substances Control
Act (15 U.S.C. 2616) is amended—
(1) in subsection
(a)—
(A) in paragraph
(1)—
(i) by
striking (1) The district courts and all that follows through
the end of subparagraph (C) and inserting the following:
(1)
Authority of
the Administrator
(A)
In
general
The Administrator may commence a civil action in the
appropriate United States district court to compel compliance of any person
with any provision of this Act or any rule or order promulgated pursuant to
this Act.
(B)
Enforcement
The
authority of the Administrator to enforce this Act includes the
authority—
(i) to seek civil or
criminal penalties under section 16 for any violation of this Act, as described
in sections 15 and 409;
(ii) to enjoin any
violation of this Act, or of a rule or order promulgated or issued under this
Act, as described in sections 15 and 409;
(iii) to order the
compliance of any person with any provision of this Act, or with any rule or
order promulgated or issued under this Act, through an administrative
proceeding (which may proceed concurrently with action under this section), in
which the Administrator may levy penalties under section 16;
and
;
and
(ii) in
subparagraph (D)—
(I) by redesignating
clause (i) through (iii) as subclauses (I) through (III), respectively, and
indenting appropriately;
(II) by striking
(D) direct any manufacturer and inserting the following:
(iv) to order any
manufacturer
;
(III) by striking
product subject to title IV and inserting article subject
to this Act;
(IV) by striking
product each place it appears and inserting
article;
(V) by striking
of section 5, 6, or title IV and inserting this
Act; and
(VI) by striking
under section 5, 6, or title IV and inserting promulgated
and issued under this Act, as described in section 15 or 409,;
(B) in paragraph
(2)—
(i) by
striking (2) A civil action and all that follows through
described in subparagraph (A) of such paragraph in subparagraph
(A) and inserting the following:
(2)
Civil
actions
(A)
In
general
The district courts of the United States shall have
jurisdiction over a civil action described in paragraph (1).
(B)
Requirements
A
civil action described in paragraph (1) may be brought—
(i) in the case of a
civil action described in subparagraphs (A) and (B) of paragraph
(1)
;
(ii) in
clause (i) (as so designated), by striking of section 15 and
inserting of this Act, as described in section 15 or 409;
(iii) by
redesignating subparagraph (B) as clause (ii) and indenting appropriately;
and
(iv) in
clause (ii) (as so designated), by striking such paragraph and
inserting paragraph (1); and
(C) in the
undesignated matter following paragraph (2), by striking In any
and inserting the following:
(3)
Serving of
process and subpoenas
In
any
;
and
(2) in the first
sentence of subsection (b)—
(A) by striking
title IV and inserting this Act;
(B) by striking
product the first place it appears and inserting
article; and
(C) by striking
product, both places it appears.
18.
Preemption
Section 18 of the Toxic Substances Control
Act (15 U.S.C. 2617) is amended to read as follows:
18.
Preemption
Nothing in this Act affects the right of a
State or a political subdivision of a State to adopt or enforce any regulation,
requirement, or standard of performance that is different from, or in addition
to, a regulation, requirement, liability, or standard of performance
established pursuant to this Act unless compliance with both this Act and the
State or political subdivision of a State regulation, requirement, or standard
of performance is impossible, in which case the applicable provisions of this
Act shall
control.
.
19.
Judicial
review
Section 19 of the Toxic
Substances Control Act (15 U.S.C. 2618) is amended—
(1) in subsection
(a)—
(A) in paragraph
(1)—
(i) by
striking subparagraph (B);
(ii) in
subparagraph (A), by striking (1)(A) Not later and all that
follows through under title II or IV, and inserting the
following:
(1)
Judicial
review
Not later than 60 days after the date of the promulgation
or issuance of a rule under of this
Act,
;
(iii) by inserting
or order after rule each place it appears;
and
(iv) in
the second sentence, by striking (other than in an enforcement
proceeding);
(B) in paragraph
(2)—
(i) in
the first sentence, by striking paragraph (1)(A) and inserting
paragraph (1); and
(ii) in
the second sentence, by inserting or order after
rule; and
(C) by striking
paragraph (3);
(2) in subsection
(b), by inserting or order after rule each place
it appears; and
(3) in subsection
(c), by striking paragraph (1) and inserting the following:
(1)
In
general
Upon the filing of a petition under subsection (a)(1) for
judicial review of a rule or order, the court shall have jurisdiction—
(A) to grant
appropriate relief, including interim relief, as provided in chapter 7 of title
5, United States Code; and
(B) to review the
rule or order in accordance with that
chapter.
.
20.
Citizens’ civil
action
Section 20 of the Toxic
Substances Control Act (15 U.S.C. 2619) is amended—
(1) in subsection
(a)—
(A) in paragraph (1),
by striking under section 4, 5, or 6, or title II or IV, or order issued
under section 5 or title II or IV to restrain such violation, and
inserting or order issued under this Act;; and
(B) in the third
sentence of the undesignated language following paragraph (2), by inserting
, to enforce this Act or any rule promulgated or order issued under this
Act, or to order the Administrator to perform an act or duty described in this
Act, as the case may be after citizenship of the
parties; and
(2) in subsection
(b)(1), by striking to restrain and inserting
respecting.
21.
Citizens’
petitions
Section 21 of the
Toxic Substances Control Act (15 U.S.C. 2620) is amended—
(1) in subsection
(a), by striking under section 4, 6, or 8 or an order under section 5(e)
or (6)(b)(2) and inserting , order, or any other action
authorized under this Act; and
(2) in subsection
(b)—
(A) in paragraph (1),
by striking under section 4, 6, or 8 or an order under section 5(e),
6(b)(1)(A), or 6(b)(1)(B) and inserting or order or to initiate
other action authorized under this Act;
(B) in the first
sentence of paragraph (3), by striking section 4, 5, 6, or 8 and
inserting the applicable provisions of this Act; and
(C) in paragraph
(4)—
(i) in
the first sentence of subparagraph (A), by striking a rulemaking
proceeding and inserting proceedings authorized under this
Act; and
(ii) in
subparagraph (B)—
(I) in the matter
preceding clause (i)—
(aa) in
the first sentence, by striking a proceeding to issue a rule under
section 4, 6, or 8 or an order under section 5(e) or 6(b)(2) and
inserting proceedings authorized under this Act; and
(bb) by
inserting Notwithstanding the preceding sentence, in the case of a
petition to delist a chemical substance under section 6(a), the delisting may
not proceed except as authorized under that subsection. after the first
sentence;
(II) in clause
(i)—
(aa) in
the matter preceding subclause (I), by striking in the case of a
petition to initiate a proceeding for the issuance of a rule under section 4 or
an order under section 5(e) and inserting except as provided in
clause (ii), in the case of a petition to initiate a proceeding for the
issuance of a rule or an order under this Act; and
(bb) in
subclause (II), by striking an unreasonable risk to and
inserting substantial endangerment; and
(III) in clause
(ii)—
(aa) by
striking issuance of a rule under section 6 or 8 or an order under
section 6(b)(2) and inserting imposition or issuance of a
restriction, use condition, or order under this chapter;
(bb) by
striking an unreasonable risk of injury and inserting a
substantial endangerment; and
(cc) by
striking the period at the end and inserting a semicolon.
22.
Employment
effects
Section 24 of the
Toxic Substances Control Act (15 U.S.C. 2623) is amended—
(1) in subsection
(a), in the matter preceding paragraph (1)—
(A) by striking
continuing and inserting periodic; and
(B) by striking
plant closures) and all that follows through the end of
paragraph (2) and inserting plant closures) of the implementation of
this Act.;
(2) in subsection
(b)—
(A) in paragraph (1),
in the undesignated language following subparagraph (B), by striking
section 4, 5, or 6 or a requirement of section 5 or 6 and
inserting this Act;
(B) in paragraph
(2)—
(i) in
subparagraph (A)(ii), by striking by order issued and inserting
in writing,; and
(ii) in
subparagraph (B)—
(I) in clause (i), by
striking the comma after such request and inserting ;
and;
(II) by striking
clause (ii); and
(III) by
redesignating clause (iii) as clause (ii); and
(C) by striking
paragraph (4); and
(3) by adding at the
end the following:
(c)
Effect
Nothing
in this section—
(1) requires the
Administrator to amend or repeal any rule or order in effect under this Act;
or
(2) conditions the
authority of the Administrator to issue orders or promulgate rules under this
Act.
.
23.
Administration
of the Toxic Substances Control Act
Section 26 of the Toxic Substances Control
Act (15 U.S.C. 2625) is amended—
(1) by striking
subsection (b) and inserting the following:
(b)
Fees
(1)
In
general
The Administrator may, by rule, require the payment of a
reasonable fee from any person required to submit data to defray the cost of
administering this Act.
(2)
Considerations
In
setting a fee under this subsection, the Administrator shall take into
account—
(A) the ability to
pay of the person required to submit the data; and
(B) the cost to the
Administrator of reviewing the data.
(3)
Fee
sharing
Rules described in paragraph (1) may provide for sharing
a fee in any case in which the expenses of testing are shared under this
Act.
;
(2) in subsection
(c)—
(A) in the subsection
heading, by adding and
mixtures after categories; and
(B) by adding at the
end the following:
(3)
Mixtures
Any
action authorized or required to be taken by the Administrator or any other
person under any provision of this Act with respect to a chemical substance is
likewise also authorized or required with respect to a mixture, if the
Administrator determines that such extension is reasonable and
efficient.
;
and
(3) by adding at the
end the following:
(h)
Rulemaking or
orders
In carrying out this Act, the Administrator may issue such
orders and prescribe such regulations as are necessary to carry out this
Act.
.
24.
State
programs
Section 28 of the
Toxic Substances Control Act (15 U.S.C. 2627) is amended—
(1) in the first
sentence of subsection (a)—
(A) by striking
unreasonable; and
(B) by striking
is unable or is not likely to take and inserting has not
taken;
(2) by redesignating
subsections (b), (c), and (d) as subsections (c), (d), and (e),
respectively;
(3) by inserting
after subsection (a) the following:
(b)
Coordination
The
Administrator shall establish a process to coordinate with States, on an
on-going basis, to share data and priorities relating to the management of
chemical substances under this title and under programs operated by States, in
accordance with section 14.
;
and
(4) in subsection
(c)(2) (as redesignated by paragraph (2)), by striking including cancer,
birth defects, and gene mutations,.
25.
Authorization
of appropriations
Title I of
the Toxic Substances Control Act (15 U.S.C. 2601 et seq.) is amended—
(1) by redesignating section 29 (15 U.S.C.
2628) as section 38;
(2) by redesignating section 30 (15 U.S.C.
2629) as section 37;
(3) by striking
section 31 (Public Law 94–469; 100 Stat. 2989); and
(4) by amending section 38 (as redesignated by
paragraph (1)) to read as follows:
38.
Authorization
of appropriations
There are
authorized to be appropriated to the Administrator to carry out this Act such
sums as are necessary for each of fiscal years 2013 through
2020.
.
26.
Additional
requirements
(a)
Restrictions on
certain chemical substances
The Toxic Substances Control Act is
amended by inserting after section 28 (15 U.S.C. 2627) the following:
29.
Children’s
Environmental Health Research Program
(a)
Children’s
Environmental Health Research Program
(1)
Establishment
Not
later than 90 days after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall establish within the Environmental Protection Agency a
program to be known as the Childrens Environmental Health
Research Program’ (referred to in this subsection as the
Program).
(2)
Purpose
Subject
to amounts made available in advance in appropriations Acts, the Administrator
may enter into contracts and make grants under the Program to further
understanding of the vulnerability of children to chemical substances and
mixtures.
(3)
Consultation
Contracts
and grants under this section shall be provided in consultation with the
Interagency Science Advisory Board on Children’s Health Research established
under subsection (b)(1).
(b)
Interagency
Science Advisory Board on Children’s Health Research
(1)
Establishment
Not
later than 90 days after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall establish an advisory board to be known as the
Interagency Science Advisory Board on Childrens Health Research’
(referred to in this subsection as the Board).
(2)
Purpose
The
purpose of the Board shall be to provide independent advice, expert
consultation, and peer review, on request of the Administrator or Congress,
with respect to the scientific and technical aspects of issues relating to the
implementation of this title with respect to research on protecting children’s
health.
(3)
Composition
The
Administrator shall—
(A) appoint the
members of the Board, including, at a minimum, representatives of—
(i) the National
Institute of Environmental Health Sciences;
(ii) the Centers for
Disease Control and Prevention;
(iii) the National
Toxicology Program;
(iv) the National
Cancer Institute;
(v) the National
EPA-Tribal Science Council; and
(vi) not fewer than 3
centers of children’s health at leading institutions of higher
education;
(B) ensure that at
least 1/3 of the members of the Board have specific
scientific expertise in the relationship of chemical exposures to prenatal,
infant, and children’s health; and
(C) ensure that no
individual appointed to serve on the Board has a conflict of interest that is
relevant to the functions performed by the Board, unless—
(i) the individual
promptly and publicly discloses the conflict; and
(ii) the
Administrator determines that the conflict is unavoidable.
(4)
Applicable
law
The Board shall be subject to subchapter II of chapter 5, and
chapter 7, of title 5, United States Code (commonly known as the
Administrative Procedure Act).
(c)
Prenatal and
infant exposures
(1)
Monitoring
If,
through studies performed under subsection (a) or section 4 or in any other
available research, the Administrator identifies a chemical substance that may
be present in human biological media that may have adverse effects on early
childhood development, the Administrator shall coordinate with the Secretary of
Health and Human Services to conduct, not later than 2 years after the date on
which the Administrator identifies the chemical substance, a biomonitoring
study to determine the presence of the chemical substance in human biological
media in, at a minimum, pregnant women and infants.
(2)
Publication
On
completion of any study conducted under paragraph (1), the Secretary of Health
and Human Services shall—
(A) notify the
Administrator of the results of the study; and
(B) publish the
results of the study in a publicly available electronic format.
(3)
Positive
results
(A)
Manufacture
disclosure
If a chemical substance or mixture is determined to be
present in a study conducted under paragraph (1), the manufacturers and
processors of the chemical substance or mixture shall, not later than 180 days
after the date of publication of the study, disclose to the Administrator,
commercial customers of the manufacturers and processors, consumers, and the
public—
(i) all known uses of
the chemical substance or mixture; and
(ii) all articles in
which the chemical substance or mixture is, or is expected to be,
present.
(B)
Cost and form
of disclosure
Information under clauses (i) and (ii) of
subparagraph (A) shall be—
(i) made available by
the Administrator in electronic format; and
(ii) made readily
accessible and free of charge by each applicable manufacturer and processor in
electronic format to the commercial customers of such manufacturer or
processor, consumers, and the public.
30.
Reduction of
animal-based testing
(a)
Administration
The
Administrator shall take action to minimize the use of animals in testing of
chemical substances or mixtures, including—
(1) encouraging and
facilitating, to the maximum extent practicable—
(A) the use of
existing data of sufficient scientific quality;
(B) the use of test
methods that eliminate or reduce the use of animals while providing data of
high scientific quality;
(C) the grouping of 2
or more chemical substances into scientifically appropriate categories in cases
in which testing of 1 chemical substance would provide reliable and useful data
on others in the category;
(D) the formation of
industry consortia to jointly conduct testing to avoid unnecessary duplication
of tests; and
(E) the parallel
submission of data from animal-based studies and from emerging methods and
models; and
(2) funding research
and validation studies to reduce, refine, and replace the use of animal tests
in accordance with this subsection.
(b)
Interagency
science advisory board on alternative testing methods
(1)
Establishment
Not
later than 90 days after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall establish an advisory board to be known as the
Interagency Science Advisory Board on Alternative Testing
Methods (referred to in this subsection and subsection (c) as the
Board).
(2)
Composition
The
Administrator shall—
(A) appoint the
members of the Board, including, at a minimum, representatives of—
(i) the National
Institute of Environmental Health Sciences;
(ii) the Centers for
Disease Control and Prevention;
(iii) the National
Toxicology Program;
(iv) the National
Cancer Institute; and
(v) the National
EPA-Tribal Science Council; and
(B) ensure that no
individual appointed to serve on the Board has a conflict of interest that is
relevant to the functions to be performed, unless—
(i) the individual
promptly and publicly discloses the conflict; and
(ii) the
Administrator determines that the conflict is unavoidable.
(3)
Purpose
The
purpose of the Board shall be to provide independent advice and peer review to
Congress and the Administrator on the scientific and technical aspects of
issues relating to the implementation of this title with respect to minimizing
the use of animals in testing chemical substances or mixtures.
(4)
Applicable
law
The Board shall be subject to subchapter II of chapter 5, and
chapter 7, of title 5, United States Code (commonly known as the
Administrative Procedure Act).
(5)
Report
Not
later than 1 year after the date of enactment of the
Safe Chemicals Act of 2013, and
every 3 years thereafter, the Administrator, in consultation with the Board,
shall publish in the Federal Register a list of testing methods that reduce the
use of animals in testing under section 4.
(c)
Implementation
of alternative testing methods
To promote the development and
timely incorporation of new testing methods that are not animal-based, the
Administrator shall—
(1) in consultation
with the Board, and after providing an opportunity for public comment, develop
a strategic plan to promote the development and implementation of alternative
test methods and testing strategies to generate information used for safety
standard determinations under section 6(b) that do not use animals, including
toxicity pathway-based risk assessment, in vitro studies, systems biology,
computational toxicology, bioinformatics, and high-throughput screening;
(2) beginning on the
date that is 2 years after the date of enactment of the
Safe Chemicals Act of 2013 and
every 2 years thereafter, submit to Congress a report that describes the
progress made in implementing this section; and
(3) fund and carry
out research, development, performance assessment, and translational studies to
accelerate the development of test methods and testing strategies that are not
animal-based for use in safety standard determinations under section
6(b).
(d)
Criteria for
adapting or waiving animal testing requirements
On request from a
manufacturer or processor that is required to conduct animal-based testing of a
chemical substance or mixture under this title, the Administrator may adapt or
waive the animal testing requirement if the Administrator determines
that—
(1) there is a
sufficient weight of evidence from several independent sources of information
to support a conclusion that a chemical substance or mixture has, or does not
have, a particular property, in any case in which the information from each
individual source alone is regarded as insufficient to support the
conclusion;
(2) because of 1 or
more physical or chemical properties of the chemical substance or mixture,
testing for a specific endpoint is technically not practicable to conduct;
or
(3) a chemical
substance or mixture cannot be tested in animals at concentrations that do not
result in significant pain or distress, because of physical or chemical
properties of the chemical substance or mixture, such as potential to cause
severe corrosion or severe irritation to tissues.
31.
Safer
alternatives and green chemistry and engineering
(a)
Safer
alternatives program
(1)
In
general
Not later than 1 year after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall establish a program to create market incentives for the
development of safer alternatives to existing chemical substances that reduce
or avoid the use and generation of hazardous substances.
(2)
Requirements
The
program established under paragraph (1) shall include—
(A) expedited review
of new chemical substances for which the manufacturer or processor submits an
alternatives analysis indicating that the new chemical substance is the safer
alternative for a particular use than existing chemical substances used for the
same purpose;
(B) recognition for a
chemical substance or product determined by the Administrator to be a safer
alternative for a particular use by means of a special designation intended for
use in marketing the safer alternative, and periodic public awards or rewards;
and
(C) such other
incentives, as the Administrator considers to be appropriate to encourage the
development, marketing, and use of chemical substances or products determined
by the Administrator to be safer alternatives for the particular uses, such as
job training and worker assistance.
(b)
Green chemistry
research network
The Administrator shall establish a network of
not less than 4 green chemistry and engineering centers, located in various
regions of the United States, to support the development and adoption of safer
alternatives to chemical substances, particularly chemical substances listed
under section 6(a).
(c)
Green chemistry
and engineering research grants
The Administrator shall make
grants to promote and support the research, development, and adoption of safer
alternatives to hazardous substances.
(d)
Green chemistry
workforce education and training program
(1)
In
general
The Administrator shall establish a program to facilitate
the development of a workforce, including industrial and scientific workers,
that produces safer alternatives to existing chemical substances.
(2)
Goals
The
goals of the program established under paragraph (1) are to provide workforce
training on skills that would—
(A) facilitate the
expansion of green chemistry;
(B) develop
scientific and technical leadership in green chemistry;
(C) facilitate the
successful and safe integration of green chemistry into infrastructure
projects;
(D) inform and engage
communities about green chemistry; and
(E) promote
innovation and strong public health and environmental protections.
(3)
Implementation
The
Administrator shall implement the program to achieve the goals of this Act,
including by—
(A) helping to
develop a broad range of skills relevant to the production and use of the safer
alternatives, including the design, manufacturing, use, and disposal of the
alternatives;
(B) offering to
develop partnerships with educational institutions, training organizations,
private sector companies, and community organizations; and
(C) providing grants
to States, units of local government, and the partnerships developed under
subparagraph (B) to promote and support activities consistent with achieving
the goals of the program established under this subsection.
32.
Cooperation
with international efforts
In
cooperation with the Secretary of State and the head of any other appropriate
Federal agency (as determined by the Administrator), the Administrator shall
cooperate with international efforts as appropriate—
(1) to develop a
common protocol or electronic database relating to chemical substances;
or
(2) to develop safer
alternatives for chemical substances.
33.
Reliable
information and advice
Not
later than 18 months after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall, by order, establish and implement procedures to ensure
data reliability including, at a minimum, requirements that the
Administrator—
(1) not less than
annually randomly inspect laboratories that develop the data required under
this title on the various properties and characteristics of a chemical
substance;
(2) annually perform
a comprehensive data audit on a subset, as chosen by the Administrator, of the
data submissions under this title;
(3) establish and
maintain a registry of all health- and safety-related studies initiated in
response to requirements under this title;
(4) have access to
all records of health- and safety-related studies initiated in response to
requirements under this title; and
(5) require the
submitter of any research study conducted by a third party in response to
requirements under this title to disclose to the Administrator and the public,
at the time of submission, the sources of any funding used for the conduct or
publication of the study received by the researchers who conducted the
study.
34.
Hot
spots
(a)
Definitions
In
this section:
(1)
Disproportionate
exposure
The term disproportionate exposure means
residential population exposure to 1 or more toxic chemical substances or
mixtures at levels that are significantly greater than the average exposure in
the United States, as defined and identified by the Administrator in accordance
with the criteria established under subsection (b).
(2)
Locality
The
term locality means any geographical area (including a county,
city, town, neighborhood, census tract, zip code area, or other commonly
understood political or geographical subdivision) in which the Administrator
identifies disproportionate exposure.
(b)
Criteria
Not
later than 180 days after the date of enactment of the
Safe Chemicals Act of 2013, the
Administrator shall promulgate a rule to establish criteria consistent with
this section that—
(1) defines
disproportionate exposure; and
(2) identifies any
locality that is disproportionately exposed.
(c)
Identification
(1)
In
general
Not later than 120 days after the date on which the rule
is promulgated under subsection (b), the Administrator shall identify
localities in the United States that are subject to disproportionate
exposure.
(2)
Use of
data
In identifying localities under paragraph (1), the
Administrator—
(A) shall use data
contained in the National Air Toxic Assessment Database; and
(B) may use other
data available to the Administrator, including data developed under—
(i) the Safe Drinking
Water Act (42 U.S.C. 300f et seq.);
(ii) the Solid Waste
Disposal Act (42 U.S.C. 6901 et seq.);
(iii) the
Comprehensive Environmental Response, Compensation, and Liability Act of 1980
(42 U.S.C. 9601 et seq.); and
(iv) the Emergency
Planning and Community Right-to-Know Act of 1986 (42 U.S.C. 11001 et
seq.).
(3)
Public
participation
The Administrator shall provide an opportunity for
members of the public to nominate localities in which disproportionate exposure
may be found for inclusion in the identification of localities under paragraph
(1).
(d)
Locality
list
(1)
In
general
Not later than 180 days after completing the
identification of localities under subsection (c)(1), the Administrator, after
notice and consultation with applicable State, local, county health, and
environmental officials, State, local, and county legislators, and other
elected officials, shall—
(A) publish a list of
the localities subject to disproportionate exposure identified under that
subsection in the Federal Register; and
(B) make the list
published under subparagraph (A) available electronically.
(2)
Updated
list
(A)
In
general
Subject to subparagraph (B), not later than 5 years after
the date on which the list is published under paragraph (1)(A), and at least
once every 5 years thereafter, the Administrator shall update and republish the
list.
(B)
Discretionary
updates
The Administrator may update and republish the list under
paragraph (1) more frequently than every 5 years—
(i) to add new
localities that meet the criteria established under subsection (b); or
(ii) to remove
localities, if the Administrator determines that the exposure reduction has
been achieved and no further action is needed after actions are taken under
subsection (f).
(C)
Notification
The
Administrator shall notify all applicable State, local, county health, and
environmental officials, State, local, and county legislators, and other
elected officials of the updated listing.
(e)
No judicial
review; nondiscretionary duty
(1)
No judicial
review
The following actions under this section shall not be
subject to judicial review:
(A) A decision to
include on the list published under subsection (d)(1) a locality identified
under subsection (c)(1).
(B) A decision in
response to nominations submitted under subsection (c)(3).
(C) A decision to
list localities under subsection (d)(1) or update the list under subsection
(d)(2).
(2)
Nondiscretionary
duty
Notwithstanding paragraph (1), the failure of the
Administrator to publish or update the list of localities in accordance with
this section shall be—
(A) considered to be
a failure to perform a nondiscretionary duty; and
(B) subject to
judicial review.
(f)
Action
plans
(1)
In
general
Not later than 1 year after the date on which the list is
published or updated under subsection (d), the Administrator shall develop and
publish, for each locality identified on the list, an action plan that
includes—
(A) an identification
of the chemical substances and mixtures that contribute to the disproportionate
exposure (including exposure levels, sources, and pathways); and
(B) a description of
actions planned by the Administrator to reduce disproportionate exposure in the
locality.
(2)
Goals
The
goal of each action plan under this subsection shall be to reduce
disproportionate exposure in the locality by establishing—
(A) a percentage
exposure reduction goal for each chemical substance and mixture; and
(B) a timeline to
achieve the percentage exposure reduction goal.
(g)
Report to
Congress
The Administrator shall—
(1) submit to
Congress an annual report that identifies—
(A) each locality
added to the list in the prior year under subsection (d);
(B) each action plan
developed in the prior year under subsection (f); and
(C) the progress on
each action plan to date; and
(2) make the report
available to the public in electronic format.
35.
Application of
this Act to Federal agencies
(a)
In
general
Except as provided in subsection (e), each Federal
agency, and any officer, agent, or employee of a Federal agency, shall be
subject to, and comply with, all applicable requirements of this Act described
in subsection (b), both substantive and procedural, in the same manner, and to
the same extent, as any person subject to the requirements.
(b)
Description of
requirements
The substantive and procedural requirements referred
to in this subsection include—
(1) any
administrative order;
(2) any civil or
administrative penalty or fine, regardless of whether the penalty or fine
is—
(A) punitive or
coercive in nature; or
(B) imposed for
isolated, intermittent, or continuing violations;
(3) any requirement
for reporting;
(4) any provision for
injunctive relief and sanctions that may be imposed by a court to enforce such
relief; and
(5) payment of
reasonable service charges.
(c)
Waiver of
immunity
The United States expressly waives any immunity
otherwise applicable to the United States with respect to any substantive or
procedural requirement referred to under subsection (a).
(d)
Civil
penalties
No agent, employee, or officer of the United States
shall be personally liable for any civil penalty under this title with respect
to any act or omission within the scope of the official duties of the agent,
employee, or officer.
(e)
Criminal
sanctions
An agent, employee, or officer of the United States
shall be subject to any criminal sanction (including any fine or imprisonment)
under this Act, but no department, agency, or instrumentality of the executive,
legislative, or judicial branch of the Federal Government shall be subject to
such sanction.
(f)
Exemption
(1)
In
general
If the President determines it is in the paramount
interest of the United States, the President may grant an exemption for any
Federal agency from compliance with any requirement of this Act.
(2)
Lack of
appropriation
No exemption shall be granted under paragraph (1)
due to lack of appropriation unless—
(A) the President has
specifically requested the appropriation as a part of the budgetary process;
and
(B) Congress has
failed to make the requested appropriation available.
(3)
Period of
exemption
Any exemption granted under paragraph (1) shall be for
a period of not more than 1 year, but additional exemptions may be granted for
periods not to exceed 1 year, if the President makes a subsequent determination
that the exemption is in the paramount interest of the United States.
(4)
Report
Each
January after the date of enactment of this section, the President shall submit
to Congress a report that describes—
(A) all exemptions
granted under this subsection during the preceding calendar year; and
(B) the reason for
granting each exemption.
(g)
Administrative
enforcement actions
(1)
In
general
The Administrator may initiate an administrative
enforcement action against any Federal agency—
(A) in accordance
with the enforcement authorities of this Act; and
(B) in the same
manner and under the same circumstances as an action would be initiated against
another person.
(2)
Settlement
Any
voluntary resolution or settlement of an administrative enforcement action
initiated under this subsection shall be set forth in a consent order.
(3)
Finality of
administrative order
No administrative order issued to a Federal
department, agency, or instrumentality under this subsection shall become final
until the Federal department, agency, or instrumentality has had the
opportunity to confer with the Administrator.
36.
Implementation
of Stockholm Convention, the LRTAP Pops Protocol, and the Rotterdam
Convention
(a)
Definitions
In
this section:
(1)
Chemical
The
term chemical includes any substance or mixture of substances,
including a substance that is part of an article.
(2)
LRTAP
Convention
The term LRTAP Convention means the
Convention on Long-Range Transboundary Air Pollution, done at Geneva on
November 13, 1979 (TIAS 10541), and any subsequent amendments to which the
United States is a party.
(3)
LRTAP Pops
chemical
The term LRTAP POPs chemical means any
chemical listed on any Annex of the LRTAP POPs Protocol, if such listing has
entered into force for the United States.
(4)
LRTAP POPS
Protocol
The term LRTAP POPs Protocol means the
Protocol on Persistent Organic Pollutants to the LRTAP Convention, done at
Aarhus on June 24, 1998, and any subsequent amendment to which the United
States is a party.
(5)
Meeting of the
parties
The term meeting of the parties
means—
(A) the Conference of
the Parties established by and operating under Article 19 of the Stockholm
Convention;
(B) the Executive
Body established by and operating under Article 10 of the LRTAP POPs
Convention; and
(C) the Conference of
the Parties established by and operating under Article 18 of the Rotterdam
Convention.
(6)
PIC
chemical
The term PIC chemical means any chemical
identified by notification to the Secretariat of the Rotterdam Convention by
the United States as banned or severely restricted in the United States, and
any chemical listed on any Annex of the Rotterdam Convention, if such listing
has entered into force for the United States.
(7)
POPs
chemical
The term POPs chemical means any chemical
that is listed on any Annex of the Stockholm Convention, if such listing has
entered into force for the United States.
(8)
Rotterdam
convention
The term Rotterdam Convention means the
Rotterdam Convention on the Prior Informed Consent Procedure for Certain
Hazardous Chemicals and Pesticides in International Trade, done at Rotterdam on
September 10, 1998, and any subsequent amendment to which the United States is
a party.
(9)
Stockholm
convention
The term Stockholm Convention means the
Stockholm Convention on Persistent Organic Pollutants, done at Stockholm on May
22, 2001, and any subsequent amendment to which the United States is a
party.
(b)
Implementation
of international agreements
(1)
In
general
The Administrator, in cooperation with appropriate
Federal agencies, shall implement and support the implementation by the United
States of the provisions of the Stockholm Convention, the LRTAP POPs Protocol,
and the Rotterdam Convention that have entered into effect for the United
States.
(2)
Prohibitions
Notwithstanding
any other provision of law, no person may manufacture, process, distribute in
commerce, use, dispose of, or take any other action with respect to a POPs
chemical, LRTAP POPs chemical, or PIC chemical in a manner inconsistent with
applicable obligations for that chemical under the Stockholm Convention, LRTAP
POPs Protocol, or Rotterdam Convention.
(3)
Public notice
and comment
(A)
In
general
The Administrator shall provide timely public notice and
opportunity to comment on a chemical proposed for listing to any Annex to the
Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam
Convention.
(B)
Contents
The
Administrator shall identify in the notice under subparagraph (A) any relevant
toxicity, exposure, and risk information on the chemical known to the
Administrator, and any domestic activities involving the chemical known to the
Administrator.
(C)
Notice and
comment
(i)
In
general
Any interested person may provide relevant comment and
information on the chemical in response to the notice under subparagraph
(A).
(ii)
Request for
information
The Administrator may require the provision of
relevant information related to a proposed chemical from any person, as the
Administrator determines necessary to assist the United States in the
review.
(iii)
Public
docket
The Administrator shall consider all comments and
information received under this subparagraph in the review of the proposal and
include the comments and information in an established public docket.
(D)
Post-recommendation
(i)
In
general
The Administrator shall provide timely public notice and
opportunity to comment after a recommendation is made to list a chemical on any
Annex to the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam
Convention.
(ii)
Meeting of the
Parties
The Administrator shall provide the notice under clause
(i) in advance of the meeting of the Parties at which the recommendation is to
be considered.
(iii)
Request for
information
The Administrator shall request comment and
information on all aspects of the recommendation and may, if the Administrator
determines it to be necessary to assist the United States in the review,
require the provision of relevant information related to a proposed chemical
from any person.
(iv)
Public
docket
The Administrator shall consider all comments and
information received under this subparagraph in the review of the proposal and
include the comments and information in an established public docket.
(E)
Decisions
(i)
In
general
Not later than 30 days after a decision by the meeting of
the parties, the Administrator shall provide timely public notice and
opportunity to comment on any decision by the meeting of the parties to list a
chemical on any Annex to the Stockholm Convention.
(ii)
Contents
The
Administrator shall provide in the notice under clause (i) a description of the
amendments to the instruments and identify the changes to the domestic
activities that the Administrator believes, based on information available to
the Administrator, would be necessary if the United States chose to be bound by
the listing decision.
(iii)
Public
comment
Any interested person may provide relevant comment and
information in response to the notice under clause (i).
(iv)
Public
docket
The Administrator shall consider all comments and
information received under this subparagraph in the review of the proposal and
include the comments and information in an established public docket.
(F)
Ratification
Not
later than 30 days after the United States deposits the instrument of
ratification for the Stockholm Convention, the LRTAP POPs Protocol, or the
Rotterdam Convention, or not later than 30 days after the listing of any
chemical subsequently added under those instruments has entered into force for
the United States (whichever date is earlier), the Administrator—
(i) shall provide
public notice of—
(I) the chemicals
that are subject to those instruments; and
(II) any chemical
subsequently added under those instruments; and
(ii) may specify the
requirements that are applicable for individual chemicals in a public notice
under this subparagraph.
(4)
General
rulemaking authority
The Administrator may promulgate regulations
necessary to carry out the Stockholm Convention, the LRTAP POPs Protocol, or
the Rotterdam Convention, or to ensure compliance with any obligations under
such instruments.
(5)
Obligations
If
a chemical is subject to obligations under more than 1 of the instruments that
includes the Stockholm Convention, the LRTAP POPs Protocol, or the Rotterdam
Convention, the most stringent of the obligations shall apply to ensure
compliance with each of the instruments.
(c)
Enforcement
The
prohibitions and any other requirements of this section shall be enforced in
the same manner as final rules or orders under section
6.
.
(b)
Conforming
amendments
The table of contents for the Toxic Substances Control
Act (15 U.S.C. 2601 et seq.) is amended—
(1) by striking the
item relating to section 2 and inserting the following:
Sec. 2. Findings, policy, and
goal.
;
(2) by striking the item relating to section 4
and inserting the following:
Sec. 4. Minimum data set and testing of
chemical
substances.
;
(3) by striking the
item relating to section 6 and inserting the following:
Sec. 6. Prioritization, safety standard
determination, and risk
management.
;
(4) by striking the
items relating to sections 29 through 31; and
(5) by adding after
the item relating to section 28 the following:
Sec. 29. Children’s Environmental Health Research
Program.
Sec. 30. Reduction of animal-based testing.
Sec. 31. Safer alternatives and green chemistry and
engineering.
Sec. 32. Cooperation with international efforts.
Sec. 33. Reliable information and advice.
Sec. 34. Hot spots.
Sec. 35. Application of this Act to Federal
agencies.
Sec. 36. Implementation of Stockholm Convention, the LRTAP Pops
Protocol, and the Rotterdam Convention.
Sec. 37. Annual report.
Sec. 38. Authorization of
appropriations.
.